MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number	2N3347
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a non-dehp micro-volume extension set was unable to prime.It was further reported, the set was disconnected from the primary tubing and attempted to prime with a normal saline flush; however, the device was ¿met with extreme resistance¿.The issue occurred during prime; therefore there was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection performed using the naked did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including clear passage and pressure testing; the device performed according to product specifications.Additional pull test was performed and no separation was observed.The reported condition was not verified.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: MICRO-VOLUME EXTENSION SET
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10638557
• Report Number: 1416980-2020-06247
• Device Sequence Number: 3303080
• Product Code: FPB
• UDI-Device Identifier: 00085412004815
• UDI-Public: (01)00085412004815
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 2N3347
• Device Lot Number: DR19K14032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE FLUSH; UNSPECIFIED ANTIBIOTIC; UNSPECIFIED PRIMARY LINE