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

Catalog Number UNKNOWN

Device Problems Material Puncture/Hole (1504); Suction Failure (4039)

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.

Event Description

It was reported that a metal hole was found on the green bulb of the drain.The nurse used tape over the hole for the drain to function properly.

Event Description

It was reported that a metal hole was found on the green bulb of the drain.The nurse used the tape over the hole for the drain to function properly.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿sharps (external or internal)." it was unknown whether the device had met specifications.The product used for the treatment but it was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bard was unable to determine the associated labeling to review.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 device was not returned.

• Brand Name: WOUND DRAINAGE
• Type of Device: EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10288460
• MDR Text Key: 199985501
• Report Number: 1018233-2020-04601
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1