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

Catalog Number	0070440
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
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 a piece of the drain broke off within the patient as the drain was being pulled out.An additional surgery was needed to remove the piece.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.To avoid the possibility of a hematoma due to wound evacuation, the instructions for use should be carefully followed.To avoid the possibility of drain damage or breakage: ¿ additional perforations should not be made in the drains.¿ avoid suturing through drains.¿ drains should lie flat and in line with the skin exit areas.¿ particular care should be taken to avoid any obstacles to the drain exit path.¿ drains should be checked during closure for free motion to avoid possibility of breakage.¿ drain removal should be done gently by hand.They should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warning: surgical removal may be necessary if drain is difficult to remove or breaks." corrections: initial reporter name and address:, initial reporter health professional, initial reporter occupation, date rec¿d by mfr.
Event or Problem Description
It was reported that a piece of the drain broke off within the patient as the drain was being pulled out.An additional surgery was needed to remove the piece.Additional information was received on (b)(6)2018 , via a medwatch, that the drain snapped at the connection between the drain and collection tube.

• Brand Name: HUBLESS SILICONE FLAT DRAIN
• Common Device Name: FLAT SILICONE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8056937
• Report Number: 1018233-2018-05289
• Device Sequence Number: 1912052
• Product Code: GBX
• UDI-Device Identifier: 00801741090769
• UDI-Public: (01)00801741090769
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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 Catalogue Number: 0070440
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/01/2018
• 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