MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN, 12.5" (31.7CM) HOLE PATTERN, TROCAR; WOUND DRAIN

Model Number	0043630
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Patient Involvement (2645); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that a hair was found in the sterile package, noticed while opening the kit during a surgical case.The product was removed from the operating room safely.
Event or Problem Description
It was reported that a hair was found in the sterile package, noticed while opening the kit during a surgical case.The product was removed from the operating room safely.
Additional Manufacturer Narrative
The reported event was unconfirmed since the problem could not be reproduced.Visual inspection noted one 3 spring evacuator was received with the original opened packaging.Visual evaluation noted no obvious defects.No hair or other foreign material was found.This meets specifications as no loosen hair in product is permitted.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN, 12.5" (31.7CM) HOLE PATTERN, TROCAR
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10580418
• Report Number: 1018233-2020-06188
• Device Sequence Number: 3885482
• Product Code: GCY
• UDI-Device Identifier: 00801741049378
• UDI-Public: (01)00801741049378
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 10/31/2024
• Device Model Number: 0043630
• Device Catalogue Number: 0043630
• Device Lot Number: NGDX4486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1