MAUDE Adverse Event Report: EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2N1333

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during the unspecified date of (b)(6) 2021.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that at least four (4) non-dehp standard bore catheter extension sets were not irrigating and were not able to flush.This was identified during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: only three (3) samples were received for evaluation.The other sample was not received and therefore, could not be evaluated.Visual inspection on the received samples did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which included ensuring the slide clamp was open, priming, purging air, attached to a male luer until secure, and opening and closing the slide clamp.All three returned samples failed clear passaged testing and pressure testing.The reported condition was verified.The cause of the condition was due to a manufacturing issue.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12519061
• MDR Text Key: 272900254
• Report Number: 1416980-2021-05873
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412475394
• UDI-Public: (01)00085412475394
• Combination Product (y/n): Y
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N1333
• Device Lot Number: UR21D21029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1