MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PG PRO 20G 10CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refr0346 showed no other similar product complaint(s) from this lot number.

Event Description

It is was reported the health professional inserted a powerglide catheter; when she went to flush, it leaked at the hub.

• Brand Name: DOT PG PRO 20G 10CM FULL
• 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
• MDR Report Key: 12455502
• MDR Text Key: 271004790
• Report Number: 3006260740-2021-03774
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110580
• UDI-Public: (01)00801741110580
• Combination Product (y/n): N
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120101
• Device Lot Number: REFR0346
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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): Other