MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY (3; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a broken picc line was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 2fr s/l per-q-cath catheter.Usage residues were observed throughout the sample.The sample was received in two segments which shared a complete break in the vicinity of the molded joint.Curved shape memory was observed in the vicinity of the break.Tactile inspection of the sample revealed abundant tensile weakness and necking in the vicinity of the break.Microscopic inspection of the break site revealed a granular fracture surface.The abundant tensile weakness and fracture features were consistent with material failure due to tensile (pulling) stress.The usage residue suggested that stress occurred during device use.A lot history review (lhr) of reds4299 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that less than two hours after placement, the hub snapped off the picc line.It was stated it was "removed intact and the infant is fine." placement info: right ac, trimmed at 14 cm.Picc got curled up and doubled back on itself in the axilla, attempted readjusting, repeated x-ray showed it still curled, pulled back to have 6cm exposed out of skin, 9cm inserted.Flushed great at the time of placement.90 minutes after placement the line snapped off at the hub.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY (3
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10028335
• Report Number: 3006260740-2020-01652
• Device Sequence Number: 766142
• Product Code: LJS
• UDI-Device Identifier: 00801741035210
• UDI-Public: (01)00801741035210
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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: 4132100
• Device Lot Number: REDS4299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 4