MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM GUI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx4780 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that lumen was leaking.No other information was provided.
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, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak was confirmed.One 5 fr sl powerpicc catheter was returned for evaluation.The winged hub was secured to a statlock securement device.The sample was flushed with water using a 12 ml syringe and a leak was observed in the extension tubing.Microscopic observation revealed a circumferential split approximately 3.5 cm from the proximal end of the tubing.The split was slightly angled.The center of the split appeared to form a low pointed peak which may be caused by a two-bladed instrument.Damage on the surface of the catheter extended beyond the split length.Additional damage was present along the split edge.The characteristics of the split suggest a sharp instrument likely contributed to the formation of the split.The product instructions for use (ifu) precautions state, "avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps." a review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Since a split in the extension tubing was found to be the source of the leak, the complaint is confirmed.A lot history review (lhr) of redx4780 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that lumen was leaking.No other information was provided.

• Brand Name: POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM GUI
• 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: 10512086
• Report Number: 3006260740-2020-03200
• Device Sequence Number: 11401545
• Product Code: LJS
• UDI-Device Identifier: 00801741027673
• UDI-Public: (01)00801741027673
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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 Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 3175135
• Device Lot Number: REDX4780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1