MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SL STIFFING STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	4134115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redz0115 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when maintaining the catheter 7 day after placement in this patient, the nurse uncovered the dressing and found that the catheter ruptured at the root.The head nurse examined the catheter and removed it.
Additional 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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a catheter break was confirmed.One 4 fr single-lumen per-q-cath picc was returned for investigation.The catheter exhibited evidence of use.The catheter was received in two sections.The tubing broke at the distal end of the taper in the molded hub.The adjoining ends of the catheter revealed an uneven surface with a granular texture, which is consistent with a break in the material.It was reported that the catheter had been in place for seven days before the break was observed.The break was reportedly detected when the dressing was removed.Tensile weakness and material necking were observed in a 7mm section of the distal catheter segment adjacent to the break site.Pulling on the catheter may have been a contributing factor of the break.No damage associated with the manufacturing process was observed on the returned sample and a review of the manufacturing records showed that the implicated lot met all release criteria.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that when maintaining the catheter 7 day after placement in this patient, the nurse uncovered the dressing and found that the catheter ruptured at the root.The head nurse examined the catheter and removed it.

• Brand Name: PER-Q-CATH PLUS 4F SL STIFFING STYLET
• Common Device Name: 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: 12050224
• Report Number: 3006260740-2021-02416
• Device Sequence Number: 3593089
• Product Code: LJS
• UDI-Device Identifier: 00801741074899
• UDI-Public: (01)00801741074899
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: 4134115
• Device Catalogue Number: 4134115
• Device Lot Number: REDZ0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other