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

Catalog Number UNKNOWN

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tip of the wound drain broke during removal.The tip was not retrieved and remained in the patient.

Manufacturer Narrative

The reported event was confirmed as cause unknown.The visual evaluation of the returned sample noted one opened (no original packaging present) used three-spring evacuator and wound drain present.The wound drain was broken upon sample receipt.The break was centered over one of the perforations in the tube intended to serve as drain holes.The diameter of the drain hole was measured (0.050") but was unable to be compared to specifications as the product catalog number of the wound drain was unknown.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the wound drain product ifus are found to be adequate based on past reviews.

Event Description

It was reported that the tip of the wound drain broke during removal.The tip was not retrieved and remained in the patient.

• Brand Name: WOUND DRAINAGE
• Type of Device: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7807217
• MDR Text Key: 118113934
• Report Number: 1018233-2018-03706
• Device Sequence Number: 1
• Product Code: GCY
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1