MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported, "in patient vessel when failure happened.While placing under ultrasound, guidewire was advanced (without difficulty) and when advancing catheter, it was not able to advance.Catheter retracted to check for tip placement.Guidewire retracted as well.Tip placement confirmed.Guidewire re-advanced without difficulty.When re-advancing catheter the same issue was noted.When removing catheter and needle as a failed attempt, it had to be pulled/forced out (like a barb) to be able to remove the needle from the patients arm." no other information was provided.
Event or Problem Description
It was reported, "in patient vessel when failure happened.While placing under ultrasound, guidewire was advanced (without difficulty) and when advancing catheter, it was not able to advance.Catheter retracted to check for tip placement.Guidewire retracted as well.Tip placement confirmed.Guidewire re-advanced without difficulty.When re-advancing catheter the same issue was noted.When removing catheter and needle as a failed attempt, it had to be pulled/forced out (like a barb) to be able to remove the needle from the patients arm." no other information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The complaint of difficult catheter insertion resulting in catheter damage was confirmed but the cause is unknown.A single photograph of the implicated powerglide catheter and deployment device was returned for evaluation.The guidewire was seen exiting through the needle bevel.The guidewire contained two severe kinks, indicating a difficult device placement or removal.The catheter was still on the deployment device but had been damaged.It appeared that the catheter had been perforated by the needle.It was reported that the catheter and guidewire had been retracted after the failed attempted advancement.It is likely that the attempt to reinsert the needle after catheter retraction likely contributed to the catheter perforation.However, the root cause of the initial difficulty advancing the catheter could not be determined.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.

• Brand Name: FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19015447
• Report Number: 3006260740-2024-01387
• Device Sequence Number: 7981664
• Product Code: FOZ
• UDI-Device Identifier: 00801741140679
• UDI-Public: (01)00801741140679
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: F320088PT
• Device Lot Number: REHU1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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