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

Model Number V0070740

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

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 the evacuator bulb suctioning for the wound received six wrong labels.Stated that six 400ml evacuator received them as a wrong label.The affected evacuators were (pcn# v0070740) and (pcn# v0043610).

Event Description

It was reported that the evacuator bulb suctioning for the wound received six wrong labels.Stated that six 400ml evacuator received them as a wrong label.The affected evacuators were (pcn# v0070740) and (pcn# v0043610).Per customer response received via mail on 01nov2022, it was stated that the bard was incorrectly labeled for v0043610 cws 400 closed wound suction kits.The wrong label said it was v0070740 -100cc silicone closed wound suction evacuator w/reflux valve.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.A potential root cause for this event could be, "incorrect line clearance".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required as a review of the label could not have prevented the reported event.The actual/suspected device was inspected.

• Brand Name: CLOSED WOUND SUCTION
• Type of Device: WOUND SUCTION
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15748506
• MDR Text Key: 306627270
• Report Number: 1018233-2022-08525
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741051609
• UDI-Public: (01)00801741051609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V0070740
• Device Catalogue Number: V0070740
• Device Lot Number: NGGT3695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other