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

Catalog Number 2N1333

Device Problem Obstruction of Flow (2423)

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 four (4) non-dehp standard bore catheter extension sets were block/clogged.It was further reported that it was impossible to empty the set unless by injecting liquid with an unspecified syringe by applying strong pressure on the plunger.This was identified during/after use (not further specified).There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: four (4) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed as follows, remove protector, ensure slide clamp is open, prime set, purge air, attach male luer until secure, open and close slide clamp as required.Additionally, clear passage and pressure tests were performed on the samples.As a result, the clear passage test failed in three (3) units and the pressure test could not be performed in the three units due to the clear passage test failure.The reported condition was not verified on one of the samples however, the reported condition of no flow was verified on the other three (3) samples.The cause of the condition was determined to be a machine related issue during the manufacturing process.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: 12456949
• MDR Text Key: 271015348
• Report Number: 1416980-2021-05610
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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
• Device Operator: Other
• Device Catalogue Number: 2N1333
• Device Lot Number: UR21D21029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/13/2021
• 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
• Treatment: UNSPECIFIED SYRINGE