MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN, 7MM; FLAT SILICONE DRAIN

Catalog Number	0071430
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/26/2017
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 information provided by bard 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 bard.
Event or Problem Description
It was reported that doctor placed the drain in the patient during carotid surgery.Upon removal of the drain, a 2-1/2 portion broke off in the patient.A sterile clamp and ultrasound machine was used to remove the piece.The patient was stable.
Additional Manufacturer Narrative
The reported issue (it was reported that doctor placed the drain in the patient during carotid surgery.Upon removal of the drain, a 2-1/2 portion broke off in the patient.A sterile clamp and ultrasound machine was used to remove the piece.The patient is stable) was confirmed, as a manufacturing related issue.During visual evaluation, it was noted that the flat drain was disconnected from the clear tube.The flat drain and clear tube were not molded correctly; which occurred during the flat drain molding process.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿precautions: 1.Avoid suturing through the drains to minimize the possibility of breakage.2.Drains should lie flat and in line with the skin exit path.3.Particular care should be taken to avoid any obstacles to the drain exit path.4.Drains should be checked for free motion during closure to minimize the possibility of breakage during/after removal.5.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or blunt instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warning: drain breakage may require surgical removal." (b)(4).
Event or Problem Description
It was reported that doctor placed the drain in the patient during carotid surgery.Upon removal of the drain, a 2-1/2 portion broke off in the patient.A sterile clamp and ultrasound machine was used to remove the piece.The patient was stable.

• Brand Name: CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN, 7MM
• Common Device Name: FLAT SILICONE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6829468
• Report Number: 1018233-2017-04528
• Device Sequence Number: 16535756
• Product Code: GCY
• UDI-Device Identifier: 00801741049668
• UDI-Public: (01)00801741049668
• 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: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: 0071430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 11/09/2017
• 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: 68 YR