MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.

Event Description

It was reported, "part of catheter was missing when it was retracted." 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.

Event Description

It was reported, "part of catheter was missing when it was retracted." no other information was provided.Comments 16/02/2024.Date of event 1/30/24.No photo available.Yes, during pt use, injury unknown.

• Brand Name: FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: 18767804
• MDR Text Key: 336115308
• Report Number: 3006260740-2024-00731
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: F320108PT
• Device Lot Number: REHS1545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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