MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION; WOUND DRAIN

Model Number	0043630
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/04/2023
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 patient surgery was done on (b)(6) 2023 and on post operative day 4, when the hemovac drain was being removed there was noted to be a break in the tubing.Computed tomography (ct) scan did not show residual drain to be superficial enough to remove it at bedside.Patient returned to the operating room (or) on (b)(6) 2023 and the portion of the drain that was retained was removed in its entirety.Removal of the drain surgery was done on the same admission as the original surgery.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿incorrect tube feeding¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "to avoid the possibility of drain damage or breakage, please follow these steps: 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 for free motion during closure to minimize the possibility of breakage.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments as these could cause cuts or nicks and lead to subsequent structural failure of the drain.Surgical removal may be necessary if drain is difficult to remove or breaks.This is a single use device.Do not reuse".H11: section a through f - 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.H3 other text: the device was not returned.
Event or Problem Description
It was reported that the patient surgery was done on (b)(6) 2023 and on post operative da 4, when the hemovac drain was being removed there was noted to be a break in the tubing.Computed tomography (ct) scan did not show residual drain to be superficial enough to remove it at bedside.Patient returned to the operating room (or) on (b)(6) 2023 and the portion of the drain that was retained was removed in its entirety.Removal of the drain surgery was done on the same admission as the original surgery.

• Brand Name: CLOSED WOUND SUCTION
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16452426
• Report Number: 1018233-2023-01293
• Device Sequence Number: 17528849
• Product Code: GCY
• UDI-Device Identifier: 00801741049378
• UDI-Public: (01)00801741049378
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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 Model Number: 0043630
• Device Catalogue Number: 0043630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown