MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that catheter sheared off and patient wound up going to the or for removal of sheared catheter.Additional information received on 21aug: it was reported the event occurred during a weekend, so the vascular surgery team was called in and took the pt to the or.In the or, they performed a cut-down procedure and foreign object removal.The product was severely deformed but removed in its entirety.
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 it will be evaluated.A supplemental will be submitted with evaluation results.
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 a broken catheter is confirmed and was determined to be use-related.One 22 ga powerglide pro was returned for evaluation.An initial visual observation revealed abundant blood use residues throughout the returned powerglide pro.The distal portion of the catheter appeared bunched.The safety mechanism was advanced approximately halfway down the needle shaft.A microscopic observation revealed the proximal end luer of the catheter to be attached to the needle shaft.The distal portion of the catheter break was observed to be attached to the advanced guidewire.The break site was observed to have striation-like patterns, and a chevron-shaped break site.The needle was observed to be broken at the flash notch location.The break site of the catheter is consistent with damage caused by pulling back the catheter along the needle, which can cause the catheter to split at the needle bevel.An examination of the catheter structure revealed no potential damage/defect related to the manufacture of the product.Collectively, the damage suggested that insertion was attempted against resistance, combined with lateral stress which damaged both the needle and the catheter.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that catheter sheared off and patient wound up going to the or for removal of sheared catheter.Additional information received on 21aug: it was reported the event occurred during a weekend, so the vascular surgery team was called in and took the pt to the operating room.In the operating room, they performed a cut-down procedure and foreign object removal.The product was severely deformed but removed in its entirety.

• Brand Name: FULL KIT 22G X 8 CM WITH 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20153841
• Report Number: 3006260740-2024-04972
• Device Sequence Number: 8397146
• Product Code: FOZ
• UDI-Device Identifier: 00801741140648
• UDI-Public: (01)00801741140648(11)240611(17)250630(10)REJR0462
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: F222088PT
• Device Lot Number: REJR0462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: Required Intervention
• Patient Sex: Unknown