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

Catalog Number	0072440
Medical Device Problem Codes	Incorrect Measurement (1383); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer looked to review product practice in regard to the 100ml silicone closed wound evacuator being connected to wall suction.There were a few sentences in the product instruction for use that customer would like some clarity on.Customer stated the dimensions of the inlet port on bulb evacuator had been changed.They used to directly connect suction tubing to this connection and use continuous wall suction.Now that the port size had been reduced, they were no longer able to get a snug connection to wall suction.Representative advised this need to be investigated.Any changes to the device should be tested so as not to affect form, fit or function.Advised this was an off-label use of the product and bd cannot promote this use or comment on the safety or effectiveness of using this device off label.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that customer looked to review product practice in regard to the 100ml silicone closed wound evacuator being connected to wall suction.There were a few sentences in the product instruction for use that customer would like some clarity on.Customer stated the dimensions of the inlet port on bulb evacuator had been changed.They used to directly connect suction tubing to this connection and use continuous wall suction.Now that the port size had been reduced, they were no longer able to get a snug connection to wall suction.Representative advised this need to be investigated.Any changes to the device should be tested so as not to affect form, fit or function.Advised this was an off-label use of the product and bd cannot promote this use or comment on the safety or effectiveness of using this device off label.
Additional Manufacturer Narrative
Per investigator evaluation, bd has determined that this mdr as not reportable as the reported event was confirmed as user related.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.

• Brand Name: CLOSED WOUND SUCTION
• Common Device Name: WOUND DRAIN
• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19690744
• Report Number: 1018233-2024-04010
• Device Sequence Number: 12779192
• Product Code: GCY
• UDI-Device Identifier: 00801741050039
• UDI-Public: (01)00801741050039
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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 Catalogue Number: 0072440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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