MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PVC DRAIN WITH TROCAR; WOUND DRAIN

Catalog Number	0080710
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/23/2025
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.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the patient was getting ready to be discharged.The hemovac wound drain that was placed during the spinal fusions needed to be pulled.The resident on call came to pull the drain and the drain broke while it was being removed.The tip remained in the patient.The patient then went to the or for an i & d.The incident extended the patients length of stay by 1 -2 days.The healthcare facility additionally indicated that the issue occurred on (b)(6) 2025 and noted the department in question as child health.This notice serves to request submission of any investigative actions undertaken (along with associated findings) and corrective measures implemented in respect of this report as soon as possible.
Event or Problem Description
It was reported that the patient was getting ready to be discharged.The hemovac wound drain that was placed during the spinal fusions needed to be pulled.The resident on call came to pull the drain and the drain broke while it was being removed.The tip remained in the patient.The patient then went to the or for an i & d.The incident extended the patients length of stay by 1 -2 days.The healthcare facility additionally indicated that the issue occurred on (b)(6) 2025 and noted the department in question as child health.This notice serves to request submission of any investigative actions undertaken (along with associated findings) and corrective measures implemented in respect of this report as soon as possible.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A dhr review is not required as the lot number is unknown.The instructions for use were found adequate and states the following: indications: warnings: when placing drain(s), care should be taken to ensure that the perforated portion of the wound drain lies completely within the confines of the wound.Wound drains are used to remove exudates from wound sites.Read product insert provided with the closed wound evacuator for detailed instructions, warnings and precautions associated with the use of the evacuator device.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 for free motion during closure to minimize the 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.¿ surgical removal may be necessary if drain is difficult to remove or breaks.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Correction- b, e.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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: PVC DRAIN WITH TROCAR
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22360144
• Report Number: 1018233-2025-05299
• Device Sequence Number: 8705774
• Product Code: GBX
• UDI-Device Identifier: 00801741050121
• UDI-Public: (01)00801741050121
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: 0080710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other
• Patient Sex: Unknown