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

Model Number	072228
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
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.The device was not returned.
Event or Problem Description
It was reported that customer used a channel drain during an abdominoplasty procedure.Customer connected it to a bulb suction and could visually see blood in the drain, but none was moving into the bulb.In fact, the bulb was only stay depressed for a couple of minutes, so they changed the bulb but got the same results.Representative informed customer that the most probable reason for this was either the tubing was compromised outside the insertion point of there was not a good seal at the wound site.The doctor reported that they had sutured around the tubing at the site and feels confident there was not issue there.
Event or Problem Description
It was reported that customer used a channel drain during an abdominoplasty procedure.Customer connected it to a bulb suction and could visually see blood in the drain, but none was moving into the bulb.In fact, the bulb was only stay depressed for a couple of minutes, so they changed the bulb but got the same results.Representative informed customer that the most probable reason for this was either the tubing was compromised outside the insertion point of there was not a good seal at the wound site.The doctor reported that they had sutured around the tubing at the site and feels confident there was not issue there.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to "tube/drain dimensions out of specification." it was unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The instructions for use were found adequate and states the following: "to avoid the possibility of drain damage or breakage: avoid suturing through drains.Drains should lie flat and in line with the skin exit areas.Particular care should be taken to avoid any obstacles to the drain exit path.Drains should be checked for free motion during closure to minimize the possibility of breakage.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Surgical removal may be necessary if drain is difficult to remove or breaks".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.H3 other text: the device was not returned.

• Brand Name: CHANNEL DRAIN
• Common Device Name: CHANNEL 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16428860
• Report Number: 1018233-2023-01157
• Device Sequence Number: 2557177
• Product Code: GBX
• UDI-Device Identifier: 00801741049880
• UDI-Public: (01)00801741049880
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 072228
• Device Catalogue Number: 072228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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