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

Catalog Number 0668945

Device Problem Material Twisted/Bent (2981)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2020

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 redq0297 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a nurse performed picc placement in a patient under ultrasound on (b)(6) 2020.After opening the package of seldinger and beginning to pre-flush the catheter, the operator found the tip of the guide wire bent.

Event Description

It was reported that a nurse performed picc placement in a patient under ultrasound on (b)(6) 2020.After opening the package of seldinger and beginning to pre-flush the catheter, the operator found the tip of the guide wire bent.

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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph of a guidewire.The depicted device was in its plastic hoop.The depicted portion included the distal end of the hoop.The guidewire was visible within the transparent hoop and could be seen to be coiled near the blue cone.While wire deformation was observed within provided photograph, inspection of the photograph was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include attempted insertion against resistance and device manipulation.

• Brand Name: 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: 11067954
• MDR Text Key: 224250697
• Report Number: 3006260740-2020-21084
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: REDQ0297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other