MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD X-FORCE BALLOON DILATION CATHETER

Model Number	997606
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
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 3 way connection parts of the catheter were found to be broken.Per additional information received via email from the ibc on 14jan2021, it was confirmed that the event occurred after the customer opened the product, and it was not used on the patient.The procedure was completed by using a new product.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for diagnostic or treatment purposes, as it was not used on a patient.An x-force dilation catheter was returned in opened packaging.Sample was inspected by unaided eye at 12" to 18" distance under normal lighting.Winged wire hub was noted to be cracked.No further visual defects were noted.A potential root cause for this failure could be "lack of training".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "inspection prior to use the x-force® balloon dilation catheter is a sterile, single use device.Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident." h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the 3 way connection parts of the catheter were found to be broken.Per additional information received via email from the ibc on 14jan2021, it was confirmed that the event occurred after the customer opened the product, and it was not used on the patient.The procedure was completed by using a new product.

• Brand Name: BARD X-FORCE BALLOON DILATION CATHETER
• Common Device Name: BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11263720
• Report Number: 1018233-2021-00225
• Device Sequence Number: 11577301
• Product Code: EZN
• UDI-Device Identifier: 00801741052101
• UDI-Public: (01)00801741052101
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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 Expiration Date: 08/29/2022
• Device Model Number: 997606
• Device Catalogue Number: 997606
• Device Lot Number: BMENFM28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other