MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G 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	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2024
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 will evaluate.Results are expected soon.
Event or Problem Description
It was reported, "placed a midline catheter on a patient in the or.Used the powerglide as is, however, the catheter broke and a surgeon had to come and do a cut down to get the retained wire/midline catheter.To their best understanding, the catheter broke off, but the surgeon was able to remove successfully." no other information was provided.
Event or Problem Description
It was reported, "placed a midline catheter on a patient in the or.Used the powerglide as is, however, the catheter broke and a surgeon had to come and do a cut down to get the retained wire/midline catheter.To their best understanding, the catheter broke off, but the surgeon was able to remove successfully." 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 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 showed blood use residues throughout the returned powerglide pro.It was observed that the needle was severely bent at the flash notch.The catheter was observed to be broken just distal of the luer.The distal segment of the catheter appeared bunched.The catheter was still attached to the needle, and the safety mechanism was not advanced over the needle tip.A microscopic observation of the catheter revealed a chevron shaped break with a granular fracture surface.The guidewire appeared to have misaligned coils along the distal tip of the guidewire.The distal weld tip of the guidewire was still intact.The observed characteristics of the break along with misaligned coils of the guidewire are typically caused by pulling the guidewire and catheter back against the needle bevel during the insertion process.The complaint of a broken catheter is confirmed and was determined to be use related.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: FULL KIT 22G 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: 18773620
• Report Number: 3006260740-2024-00763
• Device Sequence Number: 15379060
• Product Code: FOZ
• UDI-Device Identifier: 00801741140693
• UDI-Public: (01)00801741140693
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/06/2024

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: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F322088PT
• Device Lot Number: REHV2676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: Required Intervention
• Patient Sex: Unknown