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

Model Number 0070310

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the tube of the bard wound drain was found to be cut.It was stated that it was not used.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (within original packaging), used silicone round drain.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: "indications: wound drains are used to remove exudates from wound sites.Warning: 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.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.Drain placement 1.Place perforated wound drain within the critical fluid collection area of wound.2.Draw non-perforated section of wound drain through to the outside until drain indicator mark appears at the skin surface.Two sets of indicator marks aid placement of the drain.3.Remove trocar only by cutting the drain one inch from end of trocar.4.Trim non-perforated section of drain to desired length.For bard® 100cc silicone and reliavac® 100 evacuators single drain placement 1.Remove adapter with connector from pouch.2.Insert adapter end into non-perforated section of drain.3.Insert connecting tube of drain to adapter port of evacuator.For two drain placement for bard® 100cc silicone evacuators 1.Attach second drain to adapter.2.Attach connecting tube of both silicone drains to the bard® y-connector (#0070790) and connect y-connector to evacuator drain port.For reliavac® 100 (use blue adapter in drain package and y-connector in evacuator package) 1.Cut off plug from closed arm of y-connector.2.Remove blue adapters from pouches.Insert into y-connector.3.Attach both drains to blue adapters.For reliavac® 400 and 3-spring evacuators single drain placement 1.Ensure open end of y-connector is open or cut to 1/4¿ mark.2.Remove blue adapter from pouch.Insert into y-connector.3.Attach drain to blue adapter.For two drain placement 1.Cut off plug from closed arm of y-connector.2.Remove blue adapter from pouch.Insert into y-connector.3.Attach both drains to blue adapters.Reuse precaution: this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." h11:section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was evaluated.

Event Description

It was reported that the tube of the bard wound drain was found to be cut.It was stated that it was not used.

• Brand Name: BARD WOUND DRAIN
• Type of Device: BARD WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11590554
• MDR Text Key: 242985946
• Report Number: 1018233-2021-01721
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741049460
• UDI-Public: (01)00801741049460
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0070310
• Device Catalogue Number: 0070310
• Device Lot Number: NGEQ4111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other