MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2021
Type of Reportable Event	Malfunction
Additional 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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken catheter is confirmed.One 2 fr per-q-cath catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.The catheter tubing was observed to be detached from the hub within the silicone overmold portion of the hub.A microscopic observation revealed the fracture surfaces of the catheter to be mostly flat and granular in texture.The features of the break surfaces of the catheter as well as the tensile weakness observed in the catheter tubing indicate the catheter likely broke due to excessive tensile (pulling) force.A lot history review (lhr) of redt4283 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)(4).
Event or Problem Description
It was reported the catheter body was detached from the external part of the catheter, no change dressing was done, no sharp objects used close to the area.No other information was provided.

• Brand Name: PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30CM)
• 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: 12525901
• Report Number: 3006260740-2021-03963
• Device Sequence Number: 11839074
• Product Code: LJS
• UDI-Device Identifier: 00801741074820
• UDI-Public: (01)00801741074820
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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
• Report Date (Section B): 08/23/2021

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: N/A
• Device Catalogue Number: 4132005
• Device Lot Number: REDT4283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2021
• Initial Report FDA Received Date: 09/24/2021
• 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