MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SL) (65 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported that a hole at the beginning of two catheters were noted prior to use.This report addresses the second catheter.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refq3534 showed two other similar product complaint(s) from this lot number.

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 lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed.Two 3 fr single lumen per-q-cath catheters were returned for evaluation.An initial visual observation showed use residue on the returned samples.Damage was observed in the catheter tubing of both samples just distal to the strain relief of each sample.A microscopic observation revealed splits in each catheter just distal to the strain relief.Additional, more extensive damage was observed on the interior wall of each sample.The edges of these splits were observed to be rough and thin, but mostly straight.Abrasive damage was also observed near the splits on the surface of the interior wall of each sample.The shape, location, and extent of the damage observed in the returned samples indicate the catheters were most likely damaged due to excessive friction from the internal stiffening stylet, which can occur if the stylet is not properly hydrated, if the stylet is inserted or withdrawn quickly and/or at a sharp angle, or due to excessive manipulation of the stylet.

Event Description

It was reported that a hole at the beginning of two catheters were noted prior to use.This report addresses the second catheter.

• Brand Name: PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SL) (65 CM)
• 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
• 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: 13120602
• MDR Text Key: 283139078
• Report Number: 3006260740-2021-05484
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074844
• UDI-Public: (01)00801741074844
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954104
• 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,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 4133105
• Device Lot Number: REFQ3534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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