MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT 3CG 5F DL 55CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 92655517

Device Problems Retraction Problem (1536); Difficult or Delayed Separation (4044)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

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 redx0689 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).

Event Description

It was reported that there were 2 instances where the peel-away sheath is not peeling away properly.This report addresses the first event.

Event Description

It was reported that there were 2 instances where the peel-away sheath is not peeling away properly.This report addresses the first event.

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 improper ptfe sheath peel was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a 5fr ptfe microintroducer sheath.The depicted device was being used to introduce a 5fr d/l groshong catheter.The sheath handles appeared to have been separated; however, the handles appeared to have separated improperly/incompletely, leaving the catheter stuck within the sheath.While the depicted sheath appeared to have peeled improperly, inspection of the photograph was insufficient to identify the cause.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.

• Brand Name: GROSHONG NXT 3CG 5F DL 55CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11313751
• MDR Text Key: 233326207
• Report Number: 3006260740-2021-00315
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: 801(E)
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 92655517
• Device Lot Number: REDX0689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2021
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other