MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. PTFE FELT PLEDGETS; SURGICAL

Model Number	007970
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of twenty for this event.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 12/2026.
Event or Problem Description
It was reported that during preparation for a procedure, a black foreign material was allegedly found in the package upon opening the device.There was no patient contact.
Additional Manufacturer Narrative
H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of twenty for this event.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: two bard ptfe pledgets packages were returned for evaluation.During visual evaluation, no evidence of breach of sterile barrier was observed.Sample one, was noted to have discoloration and unknown material were noted within packaging.Sample two was noted to have black specs within packaging along with discoloration.Therefore, the investigation is confirmed for the reported contamination issue.A definitive root cause for the contamination issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 12/2026),.
Event or Problem Description
It was reported that during preparation for a procedure, a black foreign material was allegedly found in the package upon opening the device.There was no patient contact.

• Brand Name: PTFE FELT PLEDGETS
• Common Device Name: SURGICAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15864853
• Report Number: 2020394-2022-00932
• Device Sequence Number: 20560223
• Product Code: DXZ
• UDI-Device Identifier: 00801741041341
• UDI-Public: (01)00801741041341
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: Health Professional
• Device Model Number: 007970
• Device Catalogue Number: 007970
• Device Lot Number: HUGN2115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 11/25/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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