MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F (DUAL-LUMEN)(65CM); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	4235105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reas1378 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that according to the nurse, after positioning, the catheter broke during use.No other information provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a broken catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 5fr d/l per-q-cath catheter.The sample exhibited a complete break at the distal end of the bifurcation.The distal catheter tubing was not returned for evaluation.Usage residues were observed throughout the sample.Microscopic inspection of the break site revealed a dully granular fracture surface.Both lumens exhibited elliptical cross-sections at the fracture site.The fracture features and elliptical lumen cross-sections were consistent with damage caused by tensile (pulling) stress.The location of the damage suggested that catheter securement technique may have contributed to the break.A lot history review (lhr) of reas1378 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that according to the nurse, after positioning, the catheter broke during use.No other information provided.

• Brand Name: PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F (DUAL-LUMEN)(65CM)
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7042676
• Report Number: 3006260740-2017-02073
• Device Sequence Number: 13815626
• Product Code: LJS
• UDI-Device Identifier: 00801741074981
• UDI-Public: (01)00801741074981
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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: 4235105
• Device Catalogue Number: 4235105
• Device Lot Number: REAS1378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR