MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	32375
Medical Device Problem Codes	Contamination (1120); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the package seal and the sterility of the device were compromised.A flexima drainage catheter was selected for use.During preparation, the catheter package was ripped open upon taking out of the box.It was noted that the package seal and the sterility of the device were compromised.The procedure was completed with a different catheter.No patient complications were reported.
Event or Problem Description
It was reported that the package seal and the sterility of the device were compromised.A flexima drainage catheter was selected for use.During preparation, the catheter package was ripped open upon taking out of the box.It was noted that the package seal and the sterility of the device were compromised.The procedure was completed with a different catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The costumer attached a picture of the device, and media inspection was performed.It is possible to observe that the pouch was broken so part of the device was exposed through the pouch.The device and the pouch were returned for the analysis, and visual inspection was performed.It was possible to see that the device returned outside the pouch.Also, the pouch was broken, and it had evidence of wrinkles, so it shows that the pouch was manipulated.The catheter, the flexible cannula and a sheath were returned as part of the device, and no damages were observed.No other issues were identified during the product analysis.

• Brand Name: FLEXIMA
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15670518
• Report Number: 2124215-2022-42164
• Device Sequence Number: 20438400
• Product Code: GBO
• UDI-Device Identifier: 08714729323310
• UDI-Public: 08714729323310
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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 Expiration Date: 05/31/2025
• Device Model Number: 32375
• Device Catalogue Number: 32375
• Device Lot Number: 0029513998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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
• Patient Sex: Unknown