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

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/31/2024

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 336179033
• Report Number: 3006260740-2024-00763
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140693
• UDI-Public: (01)00801741140693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention