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

Model Number 0072360

Device Problem Component Misassembled (4004)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

It was reported that there was a presence of a silicone stopper inside the tubing of suction evacuator which was proximal to the trocar.The internal white part was perforated only on the two-third instead of whole.Therefore, it was impossible to use on craniotomy for too long as it was not perforated the full length.

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 Description

It was reported that there was a presence of a silicone stopper inside the tubing of suction evacuator which was proximal to the trocar.The internal white part was perforated only on the two-third instead of whole.Therefore, it was impossible to use on craniotomy for too long as it was not perforated the full length.

Manufacturer Narrative

The reported issue is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect set-up".It was unknown whether the device had met specifications.The product was used for treatment but it was unknown whether the product had caused the reported failure.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review is not required because labeling could not have prevented the reported issue.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: CLOSED WOUND SUCTION
• Type of Device: CLOSED 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16003905
• MDR Text Key: 307978129
• Report Number: 1018233-2022-09628
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741050008
• UDI-Public: (01)00801741050008
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0072360
• Device Catalogue Number: 0072360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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