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

Model Number	V0070740
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1018233-2022-08525
• Device Sequence Number: 19560045
• Product Code: GCY
• UDI-Device Identifier: 00801741051609
• UDI-Public: (01)00801741051609
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown