PinPointRecalls & reported problems across all models

We found 2 models of PinPoint by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Mar 13, 2018 and Dec 8, 2021 — classified as 89 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PinPoint problems

PinPoint models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PinPoint 9A10000

  Media,coupling,ultrasound
  88 reports
• PinPoint 9A10211

  Transducer, ultrasonic, diagnostic
  1 report

Recent PinPoint adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Bard Access Systems, Inc. products

• Port Access Needle122 models · 3,744 reports · 3 recalls
• Groshong NXT ClearVue Catheter8 models · 3,266 reports
• PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
• Site~Rite 8 Ultrasound System11 models · 1,965 reports
• PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
• PowerPICC Provena116 models · 1,337 reports · 2 recalls
• PowerPort M.R.I., Groshong10 models · 1,285 reports
• Navarre15 models · 1,228 reports