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

Model Number	30935
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2022 as the event date was not reported.
Event or Problem Description
It was reported that there was hair inside the sealed package.A flexima all purpose drainage catheter was selected for use.During shipment, it was noted that there was hair inside the sealed package.There was no patient involvement.
Event or Problem Description
It was reported that there was hair inside the sealed package.A flexima all purpose drainage catheter was selected for use.During shipment, it was noted that there was hair inside the sealed package.There was no patient involvement.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was not returned; however, an analysis was concluded based on the received photo of the complaint device.Media inspection was performed, and a hair inside the pouch of the device was observed.No other issues were identified during the analysis.B3 - date of event: used 12/01/2022 as the event date was not reported.H3 other text : media review.

• Brand Name: FLEXIMA APDL
• 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: 16258598
• Report Number: 2124215-2023-01484
• Device Sequence Number: 20088556
• Product Code: FFA
• UDI-Device Identifier: 08714729323143
• UDI-Public: 08714729323143
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 07/12/2025
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0029758990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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