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

Catalog Number	072510
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
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.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 has some issues with one of the wound drainage accessories.The below item was listed as comparable to the bcc1 and bcc2 from ethicon, but our cvor area was advising that the caps do not stay on the new bard medical.These caps will not provide a tight seal and can come off.Item 072510 was an exact cross for bcc3 ,3 in 1 connector but was not a like for like for the other two, bcc1 and bcc2.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿dimensions of the adapter incorrect, adapter mechanically damaged".However, there was insufficient information to confirm this potential root cause.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.This is a single use device.Do not resterilize any portion of this device.Reuse and or repackaging may create a risk of patient or user infection, compromise the structural integrity and or essential material and design characteristics of the device, which may lead to device failure, and or lead to injury, illness or death of the patient.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician." 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.
Event or Problem Description
It was reported that customer has some issues with one of the wound drainage accessories.The below item was listed as comparable to the bcc1 and bcc2 from ethicon, but our cvor area was advising that the caps do not stay on the new bard medical.These caps will not provide a tight seal and can come off.Item 072510 was an exact cross for bcc3 ,3 in 1 connector but was not a like for like for the other two, bcc1 and bcc2.

• Brand Name: CARDIOTHORACIC ADAPTOR
• Common Device Name: WOUND DRAIN-CARDIOTHORACIC ADAPTOR
• 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: 19793305
• Report Number: 1018233-2024-04413
• Device Sequence Number: 4144894
• Product Code: GCE
• UDI-Device Identifier: 00801741050046
• UDI-Public: (01)00801741050046
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/13/2024

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: 072510
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/18/2024
• 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