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

Catalog Number	2N1333
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the luer of a non-dehp standard bore catheter extension set broke off.It was further reported that the clamp "cut through" the tubing.It was not specified when in the process this occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10:the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.The reported condition is not clearly observed via the provided photographs and due to the nature of the returned sample no additional testing could be performed.Therefore, the reported problem could not be verified or refuted.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
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10130698
• Report Number: 1416980-2020-03190
• Device Sequence Number: 3636268
• Product Code: FPA
• UDI-Device Identifier: 00085412475394
• UDI-Public: (01)00085412475394
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: UR20A21034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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: NI.