MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL SILICONE ROUND SINGLE DRAIN; BARD WOUND DRAIN

Model Number	0070210
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	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a blue string/fiber found inside the package of wound drain.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The reported failure is within specification as the reported failure could not be reproduced.The product was not used for patient treatment or diagnosis.The product had not caused the reported failure.Visual evaluation of the returned sample noted one unopened (within original packaging), unused silicone round drain.Visual inspection of the sample noted no obvious visible defects or foreign material within the packaging.The packaging was opened, and still no foreign material was found.No root cause could be found because the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed a labeling review is not required.The actual/suspected device was inspected.
Event or Problem Description
It was reported that there was a blue string/fiber found inside the package of wound drain.Per form received with return sample on 08dec2021, it was stated that the product was pick for the case prior to opening the package, the staff nurse spotted the particle, and the item did not get to the operation room.

• Brand Name: DAVOL SILICONE ROUND SINGLE DRAIN
• Common Device Name: BARD WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12920475
• Report Number: 1018233-2021-07703
• Device Sequence Number: 4994608
• Product Code: GBX
• UDI-Device Identifier: 00801741049439
• UDI-Public: (01)00801741049439
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 0070210
• Device Catalogue Number: 0070210
• Device Lot Number: NGFNX215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown