MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number SP4153108DB

Device Problem Material Deformation (2976)

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

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer is confirmed; however, the exact cause is unknown.One 3.5 fr x 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal tip of the sheath was observed to be damaged and an approximately 1 cm length of the sheath was observed to be buckled about 1 cm proximal to the sheath tip.The distal end of the dilator was observed to be bent.A microscopic observation revealed the distal tip of the introducer sheath was damaged and plastically deformed in multiple locations around its circumference.One edge of the tip of the introducer sheath was observed to be folded inward and over itself, and another edge of the tip was observed to be buckled.While the root cause of the damage observed on the introducer sheath is unknown, possible causes include damage during handling or use.A lot history review (lhr) of reep4196 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported microintroducer buckled when trying to insert.No other information was provided.(b)(6) 2021: it was found that the introducer sheath tip was flared and damaged on the returned sample.

• Brand Name: DOT 3FR SL PROV ML
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11474630
• MDR Text Key: 240438054
• Report Number: 3006260740-2021-00798
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2021

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 Model Number: SP4153108DB
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REEP4196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2020
• 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