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

Catalog Number	2N1333
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12519061
• Report Number: 1416980-2021-05873
• Device Sequence Number: 14511113
• Product Code: FPA
• UDI-Device Identifier: 00085412475394
• UDI-Public: (01)00085412475394
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1