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

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the device became blocked/clogged.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure could be "channels kinked or collapsed during use".The lot number is unknown therefore the device history record could not be reviewed.The product family for this wound drainage product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the wound drainage product ifus are found to be adequate based on past reviews.

Event Description

It was reported that the device became blocked/clogged.

• Brand Name: WOUND DRAINAGE
• Type of Device: WOUND DRAINAGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8776095
• MDR Text Key: 150694183
• Report Number: 1018233-2019-03789
• 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,study
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1