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

Catalog Number 0070310

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2020

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 a foreign material was found in the evacuator before use.

Manufacturer Narrative

The reported event was unconfirmed.Visual inspection noted one silicone round drain was received in unopened original packaging.Visual evaluation noted one small cardboard-like material measuring 0.30 sq mm inside the outer packaging.This meets specifications stating that inspect for loose foreign or parent matter not to exceed 1/32" in length or 0.4mm^2.A device history record review was not required per the investigation.A labeling review was not performed because labeling could not have prevented the reported failure.Correction: d2.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.

Event Description

It was reported that a foreign material was found in the wound drain before use.As per additional information received via email on 05aug2020 from ibc representative, it seemed that the foreign material was found inside the package.

• Brand Name: BARD WOUND DRAIN
• Type of Device: BARD WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10346206
• MDR Text Key: 202361133
• Report Number: 1018233-2020-04868
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070310
• Device Lot Number: NGDZ3040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Date Manufacturer Received: 10/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1