MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F; INTRODUCER, CATHETER

Model Number N/A

Device Problem Defective Component (2292)

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

Event Date 10/25/2021

Event Type  malfunction  

Event Description

It was reported the patient received picc catheter at 15:00 today, and a "seding sleeve" was applied to insert the backward guide wire needle.A hook was found at the end of the guide wire when the needle was inserted, which made it difficult to withdraw the needle and affected puncture.The guide wire was replaced, and the patient was explained and understood.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redv2725 showed one other similar product complaint(s) from this lot number.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F
• Type of Device: INTRODUCER, CATHETER
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12839998
• MDR Text Key: 281030804
• Report Number: 3006260740-2021-04943
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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: 0668945
• Device Lot Number: REDV2725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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