MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER

Catalog Number 0668945

Device Problem Defective Component (2292)

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

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redw3490 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that this patient had a catheter placed and the guide wire was inserted after puncture was done successfully under ultrasound.When removing the introducer needle, the guide wire was almost withdrawal along with the introducer needle due to a barb at the tip of the guide wire.The guide wire was then removed and cut off its tip, and re-inserted for the placement of vascular sheath.

Event Description

It was reported that this patient had a catheter placed and the guide wire was inserted after puncture was done successfully under ultrasound.When removing the introducer needle, the guide wire was almost withdrawal along with the introducer needle due to a barb at the tip of the guide wire.The guide wire was then removed and cut off its tip, and re-inserted for the placement of vascular sheath.

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 following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed but the exact cause remains unknown.One photo sample of a guidewire was provided for evaluation.The guidewire is being held by a clinician outside of the patient.Blood residue is present on the device.The tip of the wire appears to have a slight curvature.It could not be clearly inspected for additional damage or fractures.Based on the description of the reported event, possible contributing factors include damage during handling or frayed wire.Due to the lack of a physical sample, the exact type of damage and cause could not be determined.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11713623
• MDR Text Key: 247221548
• Report Number: 3006260740-2021-01491
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0668945
• Device Lot Number: REDW3490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2021
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other