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

Model Number 0070310

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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 there were marks that looked like cut with scissors on the package.It was stated that the device was not used.

Manufacturer Narrative

The reported event was confirmed cause unknown.2 samples were confirmed to exhibit the reported failure.The devices had not met specifications.The product was used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted three opened (within original packaging), unused round drains.Visual inspection of the samples noted that 2 of the wound drain samples had straight cuts on their inner pouches.This does not meet the specifications.A potential root cause for this failure could be damage to pouch caused by metallic hooks during manufacturing.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.Corrections: d,h.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 actual/suspected device was evaluated.

Event Description

It was reported that there were marks that looked like cut with scissors on the package.It was stated that the device 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: 11590555
• MDR Text Key: 243356439
• Report Number: 1018233-2021-01720
• 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: 08/20/2021

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: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other