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); Material Frayed (1262)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Foreign Body In Patient (2687)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that resistance was met while trying to thread catheter.Two nurses attempted to thread with no success.They attempted to remove the whole device but it would not come out easily.Ordered ultrasound to see that the catheter was still intact.The device was then removed, and the catheter was sheared off.8/7/2024 additional information received: it was reported x-ray confirmed break.Patient had the catheter surgically removed the next day.Patient reported pain and discomfort when pulling catheter and device out of arm.All pieces removed from the patient.
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 catheter break is confirmed and was determined to be use-related.One 22 ga powerglide pro was returned for evaluation.The investigation findings are consistent with catheter damage caused by contact with a sharp-edged instrument such as the introducer needle bevel.The returned product sample was evaluated and a break in the catheter was observed at the proximal end of the catheter.Microscopic examination of the catheter break confirmed it was typical of contact with a needle, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on the bevel of a needle.The fracture edges were sharply formed and had planar (flat) surfaces.The damage also contained the overall shape of a chevron 'v'.This shape is common to many needle bevels, and this shape is often transferred onto the catheter when punctured by a needle.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that resistance was met while trying to thread catheter.Two nurses attempted to thread with no success.They attempted to remove the whole device but it would not come out easily.Ordered ultrasound to see that the catheter was still intact.The device was then removed, and the catheter was sheared off.8/7/2024 additional information received: it was reported x-ray confirmed break.Patient had the catheter surgically removed the next day.Patient reported pain and discomfort when pulling catheter and device out of arm.All pieces removed from the patient.

• 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: 20097263
• Report Number: 3006260740-2024-04849
• Device Sequence Number: 8442317
• Product Code: FOZ
• UDI-Device Identifier: 00801741140648
• UDI-Public: (01)00801741140648(11)240202(17)250228(10)REJN2429
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/08/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: F222088PT
• Device Lot Number: REJN2429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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 Age: 17 YR
• Patient Sex: Unknown