PinPoint 9A10000Recalls & reported problems
Bard Access Systems, Inc. · PinPnt Gelcap, wo guide, 50 Proc · Class 2
Quick summary
This Bard PinPoint ultrasound gel cap is a disposable capsule of coupling gel used during ultrasound procedures. The 88 reports, all from 2021, mostly describe mold or black specks found inside the gel caps when packages were opened, with no injuries and no deaths reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00801741091209), received between Aug 12, 2021 and Dec 8, 2021 — classified as 88 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (87 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem87
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions88
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED CONTAMINATED GEL CAPS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12964707 ↗MalfunctionNov 11, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED "WHEN CUSTOMER WENT TO USE GEL CAPS FOR PREVUE, ONE PACKAGE WAS OPENED AND BLACK DOTS WHICH LOOKED LIKE MOLD WERE INSIDE THE GEL CAPS." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12797715 ↗MalfunctionNov 11, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "UPON OPENING THE PACKAGE, THERE IS MOLD IN THE GEL CAPS". NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12797465 ↗MalfunctionNov 11, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "UPON OPENING THE PACKAGE, THERE IS MOLD IN THE GEL CAPS". NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12797344 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 50TH GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594908 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 54THGEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594891 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 49TH GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594885 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 44TH GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594833 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 43RD GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594813 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 53RD GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594796 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 48TH GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594789 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 51ST GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594786 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 52ND GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594763 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 47TH GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594672 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 45TH GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594669 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATED THAT WHEN THEY OPEN THE PACKAGE THERE WAS MOLD IN THE PRODUCT." THIS OCCURRED WITH 54 GEL CAP DEVICES. THIS REPORT ADDRESSES THE 46TH GEL CAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594657 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE WAS MOLD NOTED IN THE PINPOINT GEL CAPS. NO OTHER INFORMATION WAS PROVIDED. 21 GEL CAP SAMPLES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE 18TH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594656 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE WAS MOLD NOTED IN THE PINPOINT GEL CAPS. NO OTHER INFORMATION WAS PROVIDED. 21 GEL CAP SAMPLES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE 15TH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594651 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE WAS MOLD NOTED IN THE PINPOINT GEL CAPS. NO OTHER INFORMATION WAS PROVIDED. 21 GEL CAP SAMPLES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE 17TH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594609 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE WAS MOLD NOTED IN THE PINPOINT GEL CAPS. NO OTHER INFORMATION WAS PROVIDED. 21 GEL CAP SAMPLES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE 14TH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594598 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE WAS MOLD NOTED IN THE PINPOINT GEL CAPS. NO OTHER INFORMATION WAS PROVIDED. 21 GEL CAP SAMPLES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594556 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE WAS MOLD NOTED IN THE PINPOINT GEL CAPS. NO OTHER INFORMATION WAS PROVIDED. 21 GEL CAP SAMPLES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE 10TH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594526 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE WAS MOLD NOTED IN THE PINPOINT GEL CAPS. NO OTHER INFORMATION WAS PROVIDED. 21 GEL CAP SAMPLES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE 20TH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594515 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE WAS MOLD NOTED IN THE PINPOINT GEL CAPS. NO OTHER INFORMATION WAS PROVIDED. 21 GEL CAP SAMPLES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE 13TH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594505 ↗MalfunctionOct 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE WAS MOLD NOTED IN THE PINPOINT GEL CAPS. NO OTHER INFORMATION WAS PROVIDED. 21 GEL CAP SAMPLES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE NINTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594501 ↗
Other Media,coupling,ultrasound devices
- Medline MDS092005Medline Industries, Inc. · Media, coupling, ultrasound1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.