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

Model Number 32375

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Event 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 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 333503624
• Report Number: 2124215-2024-01634
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 08714729323310
• UDI-Public: 08714729323310
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/07/2024; 03/06/2024
• Supplement Dates FDA Received: 02/22/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2023
• 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