MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 HUBLESS SILICONE FLAT DRAIN; SILICONE DRAIN

Catalog Number	0070440
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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 the was a strand of hair in the packaging of the drain.
Event or Problem Description
It was reported that there was a strand of hair in the drain package.
Additional Manufacturer Narrative
The reported event was confirmed, however the cause was unknown.The device used for the treatment.The device would not meet the specifications, and was affected by the reported failure.Visual evaluation of the returned sample noted that one opened (in original packaging), unused silicone flat drain.It was noted that there was a long curly hair within the package on top of the tubing portion of the drain.Although the reported event was confirmed, the root cause could not be determined.A potential root cause of this failure could be due to a defective /contaminated components from the supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to the labelling could not prevent 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: HUBLESS SILICONE FLAT DRAIN
• Common Device Name: SILICONE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10070858
• Report Number: 1018233-2020-03269
• Device Sequence Number: 14358206
• Product Code: GBX
• UDI-Device Identifier: 00801741090769
• UDI-Public: (01)00801741090769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 12/31/2024
• Device Catalogue Number: 0070440
• Device Lot Number: NGDZ1061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1