Deltec 21-3369-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10610586033025), received between Jan 13, 2023 and Jan 13, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K072657); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Loose or Intermittent Connection; Obstruction of Flow; Loose or Intermittent Connection; Obstruction of Flow

  IT WAS REPORTED THAT THE MICROCLAVE UNSCREWED FROM THE GRIPPER THROUGHOUT THE TREATMENT WITH AN INFUSOR. IT OCCURRED WITH 4 PATIENTS AND AT THE END OF THE TREATMENT THERE WAS A LOT OF BLEEDBACK OBSTRUCTING THE LINE. THERE WAS SPILLAGE OF DRUG AND BLOOD THROUGH THE CONNECTION OF THE MICROCLAVE AND GRIPPER. THERE WAS BLOOD LOSS, BLEEDBACK, CHEMO, AND BIOHAZARD. THE DEVICE WAS NOT REPROCESSED OR RE-STERILIZED. THERE IS A USED CONTAMINATED SAMPLE AND SISTER SAMPLES AVAILABLE FOR EVALUATION. FIVE PICTURES OF THE PRODUCT ISSUE WERE PROVIDED. THE EVENT OCCURRED DURING PATIENT USE; HOWEVER, THERE WAS NO NEED FOR MEDICAL INTERVENTION, NO DELAY IN THERAPY, NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THIS EVENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 20-DEC-2022: RECEIVED AN EMAIL FROM THE SALES REPRESENTATIVE ON 20-DEC-2022, STATING THAT THE MICROCLAVE WAS UNSCREWING FROM THE LUER OF THE GRIPPER WHILE THE INFUSER TREATMENT WAS PASSING. WHEN THE MICROCLAVE WAS LOOSENED FROM THE GRIPPER CONNECTION, BLOOD FLEW BACK AS THE GRIPPER WAS OPENED. THE BLOOD REFLUXED FROM THE PORT-A-CATH INTO THE ELASTOMER WHEN THE DRUG FINISHED PASSING. THE GRIPPER WAS PLACED FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157506 ↗
• MalfunctionJan 13, 2023Loose or Intermittent Connection; Obstruction of Flow; Loose or Intermittent Connection; Obstruction of Flow

  IT WAS REPORTED THAT THE MICROCLAVE UNSCREWED FROM THE GRIPPER THROUGHOUT THE TREATMENT WITH AN INFUSOR. IT OCCURRED WITH 4 PATIENTS AND AT THE END OF THE TREATMENT THERE WAS A LOT OF BLEEDBACK OBSTRUCTING THE LINE. THERE WAS SPILLAGE OF DRUG AND BLOOD THROUGH THE CONNECTION OF THE MICROCLAVE AND GRIPPER. THERE WAS BLOOD LOSS, BLEEDBACK, CHEMO, AND BIOHAZARD. THE DEVICE WAS NOT REPROCESSED OR RE-STERILIZED. THERE IS A USED CONTAMINATED SAMPLE AND SISTER SAMPLES AVAILABLE FOR EVALUATION. FIVE PICTURES OF THE PRODUCT ISSUE WERE PROVIDED. THE EVENT OCCURRED DURING PATIENT USE; HOWEVER, THERE WAS NO NEED FOR MEDICAL INTERVENTION, NO DELAY IN THERAPY, NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THIS EVENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 20-DEC-2022: RECEIVED AN EMAIL FROM THE SALES REPRESENTATIVE ON 20-DEC-2022, STATING THAT THE MICROCLAVE WAS UNSCREWING FROM THE LUER OF THE GRIPPER WHILE THE INFUSER TREATMENT WAS PASSING. WHEN THE MICROCLAVE WAS LOOSENED FROM THE GRIPPER CONNECTION, BLOOD FLEW BACK AS THE GRIPPER WAS OPENED. THE BLOOD REFLUXED FROM THE PORT-A-CATH INTO THE ELASTOMER WHEN THE DRUG FINISHED PASSING. THE GRIPPER WAS PLACED FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157469 ↗
• MalfunctionJan 13, 2023Loose or Intermittent Connection; Obstruction of Flow; Loose or Intermittent Connection; Obstruction of Flow

  IT WAS REPORTED THAT THE MICROCLAVE UNSCREWED FROM THE GRIPPER THROUGHOUT THE TREATMENT WITH AN INFUSOR. IT OCCURRED WITH 4 PATIENTS AND AT THE END OF THE TREATMENT THERE WAS A LOT OF BLEEDBACK OBSTRUCTING THE LINE. THERE WAS SPILLAGE OF DRUG AND BLOOD THROUGH THE CONNECTION OF THE MICROCLAVE AND GRIPPER. THERE WAS BLOOD LOSS, BLEEDBACK, CHEMO AND BIOHAZARD. THE DEVICE WAS NOT REPROCESSED OR RE-STERILIZED. THERE IS A USED CONTAMINATED SAMPLE AND SISTER SAMPLES AVAILABLE FOR EVALUATION. FIVE PICTURES OF THE PRODUCT ISSUE WERE PROVIDED. THE EVENT OCCURRED DURING PATIENT USE; HOWEVER, THERE WAS NO NEED FOR MEDICAL INTERVENTION, NO DELAY IN THERAPY, NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THIS EVENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 20-DEC-2022: RECEIVED AN EMAIL FROM THE SALES REPRESENTATIVE ON 20-DEC-2022, STATING THAT THE MICROCLAVE WAS UNSCREWING FROM THE LUER OF THE GRIPPER WHILE THE INFUSER TREATMENT WAS PASSING. WHEN THE MICROCLAVE WAS LOOSENED FROM THE GRIPPER CONNECTION, BLOOD FLEW BACK AS THE GRIPPER WAS OPENED. THE BLOOD REFLUXED FROM THE PORT-A-CATH INTO THE ELASTOMER WHEN THE DRUG FINISHED PASSING. THE GRIPPER WAS PLACED FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157445 ↗
• MalfunctionJan 13, 2023Loose or Intermittent Connection; Obstruction of Flow; Loose or Intermittent Connection; Obstruction of Flow

  IT WAS REPORTED THAT THE MICROCLAVE UNSCREWED FROM THE GRIPPER THROUGHOUT THE TREATMENT WITH AN INFUSOR. IT OCCURRED WITH 4 PATIENTS AND AT THE END OF THE TREATMENT THERE WAS A LOT OF BLEEDBACK OBSTRUCTING THE LINE. THERE WAS SPILLAGE OF DRUG AND BLOOD THROUGH THE CONNECTION OF THE MICROCLAVE AND GRIPPER. THERE WAS BLOOD LOSS, BLEEDBACK, CHEMO, AND BIOHAZARD. THE DEVICE WAS NOT REPROCESSED OR RE-STERILIZED. THERE IS A USED CONTAMINATED SAMPLE AND SISTER SAMPLES AVAILABLE FOR EVALUATION. FIVE PICTURES OF THE PRODUCT ISSUE WERE PROVIDED. THE EVENT OCCURRED DURING PATIENT USE; HOWEVER, THERE WAS NO NEED FOR MEDICAL INTERVENTION, NO DELAY IN THERAPY, NO ADVERSE EVENT, AND NO ONE WAS HARMED AS A RESULT OF THIS EVENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 20-DEC-2022: RECEIVED AN EMAIL FROM THE SALES REPRESENTATIVE ON 20-DEC-2022, STATING THAT THE MICROCLAVE WAS UNSCREWING FROM THE LUER OF THE GRIPPER WHILE THE INFUSER TREATMENT WAS PASSING. WHEN THE MICROCLAVE WAS LOOSENED FROM THE GRIPPER CONNECTION, BLOOD FLEW BACK AS THE GRIPPER WAS OPENED. THE BLOOD REFLUXED FROM THE PORT-A-CATH INTO THE ELASTOMER WHEN THE DRUG FINISHED PASSING. THE GRIPPER WAS PLACED FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157380 ↗
• MalfunctionJan 13, 2023Loose or Intermittent Connection; Obstruction of Flow; Loose or Intermittent Connection; Obstruction of Flow

  IT WAS REPORTED THAT THE MICROCLAVE UNSCREWED FROM THE GRIPPER THROUGHOUT THE TREATMENT WITH AN INFUSOR. IT OCCURRED WITH 4 PATIENTS AND AT THE END OF THE TREATMENT THERE WAS A LOT OF BLEEDBACK OBSTRUCTING THE LINE. THERE WAS SPILLAGE OF DRUG AND BLOOD THROUGH THE CONNECTION OF THE MICROCLAVE AND GRIPPER. THERE WAS BLOOD LOSS, BLEEDBACK, CHEMO AND BIOHAZARD. THE DEVICE WAS NOT REPROCESSED OR RE-STERILIZED. THERE IS A USED CONTAMINATED SAMPLE AND SISTER SAMPLES AVAILABLE FOR EVALUATION. FIVE PICTURES OF THE PRODUCT ISSUE WERE PROVIDED. THE EVENT OCCURRED DURING PATIENT USE; HOWEVER, THERE WAS NO NEED FOR MEDICAL INTERVENTION, NO DELAY IN THERAPY, NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THIS EVENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 20-DEC-2022: RECEIVED AN EMAIL FROM THE SALES REPRESENTATIVE ON 20-DEC-2022, STATING THAT THE MICROCLAVE WAS UNSCREWING FROM THE LUER OF THE GRIPPER WHILE THE INFUSER TREATMENT WAS PASSING. WHEN THE MICROCLAVE WAS LOOSENED FROM THE GRIPPER CONNECTION, BLOOD FLEW BACK AS THE GRIPPER WAS OPENED. THE BLOOD REFLUXED FROM THE PORT-A-CATH INTO THE ELASTOMER WHEN THE DRUG FINISHED PASSING. THE GRIPPER WAS PLACED FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157325 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072657. One submission often covers many models, so check the product and lot details in each record.

• Z-2499-2020 · Jun 11, 2020 · Terminated
  PORT-A-CATH II POWER P.A.C. Low Profile" system.
• Z-0190-2020 · Jul 8, 2019 · Terminated
  GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2.