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

Model Number	32375
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device packaging seal was compromised.A 10.3 flexima drainage catheter was selected for use.However, it was noted that there was a hole in the packaging, and the seal was compromised.There was no patient or procedure involved.
Event or Problem Description
It was reported that device packaging seal was compromised.A 10.3 flexima drainage catheter was selected for use.However, it was noted that there was a hole in the packaging, and the seal was compromised.There was no patient or procedure involved.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.It is possible to observed that the package was ripped/torn, wrinkles were observed at the torn section and with waste/residues were inside the package at torn section.Also, the photo attached on the complaint shows a hole on the device pouch.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device packaging seal was compromised.A 10.3 flexima drainage catheter was selected for use.However, it was noted that there was a hole in the packaging, and the seal was compromised.There was no patient or procedure involved.
Additional Manufacturer Narrative
Device eval by mfr: the device was not returned.However, a photo was provided from the healthcare facility.It shows a hole on the device pouch.

• Brand Name: FLEXIMA
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18565438
• Report Number: 2124215-2024-01634
• Device Sequence Number: 17845297
• Product Code: GBO
• UDI-Device Identifier: 08714729323310
• UDI-Public: 08714729323310
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2024

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: Health Professional
• Device Expiration Date: 08/09/2026
• Device Model Number: 32375
• Device Catalogue Number: 32375
• Device Lot Number: 0032191536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/07/2024; 03/06/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/22/2024; 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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