MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 HUBLESS SILICONE FLAT DRAIN, X-RAY OPAQUE STRIPE, 20CM LONG, FULL-LENGTH PERFORA; FLAT SILICONE DRAIN

Catalog Number	0070440
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the hubless silicone flat drain broke off in the patient.The patient required additional surgery in order for the broken piece to be removed.Per additional information received on the medwatch on 05-feb-2019: the drain was placed during a lumbar fusion.Two days after the procedure, the physician was removing the drain and the drain broke.The surgeon noted that the drain was not near any suture.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (without original packaging) used bulb evacuator attached to a broken tubing, which was attached to a broken flat drain.The tubing was broken 0.419" from the flat drain while 2.7765" of the flat drain was broken off and not returned.Broken drains and tubes are out of specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿warning: do not bypass/inactivate anti-reflux valve.Important:" correction: concomitant medical products, device evaluated by mfr.Patient code: 2564.
Event or Problem Description
It was reported that the hubless silicone flat drain broke off in the patient.The patient required additional surgery in order for the broken piece to be removed.Per additional information received on the medwatch on 05-feb-2019: the drain was placed during a lumbar fusion.Two days after the procedure, the physician was removing the drain and the drain broke.The surgeon noted that the drain was not near any suture.

• Brand Name: HUBLESS SILICONE FLAT DRAIN, X-RAY OPAQUE STRIPE, 20CM LONG, FULL-LENGTH PERFORA
• Common Device Name: FLAT SILICONE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8342788
• Report Number: 1018233-2019-00815
• Device Sequence Number: 1915201
• Product Code: GBX
• UDI-Device Identifier: 00801741090769
• UDI-Public: (01)00801741090769
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 0070440
• Device Lot Number: NGCN1148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR