MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 5F, TL, TT, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	CK000079D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 for evaluation.A lot history review (lhr) of rebr1443 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported icu patient pulled on the picc and the center red lumen came off the extension leg.There was no patient harm reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 break is confirmed and appears to be use related.One 5 f powerpicc solo catheter was returned for investigation.Use residue was observed within the device.The red connector was returned detached from the extension leg.The extension tubing was observed to have fractured from within the distal end of the hub.Microscopic observation of the break revealed an uneven and granular surface.The sharp rise in the break surface is indicative of tensile force being applied to the extension leg.Based on the description of the reported event and condition of the returned sample, the complaint is confirmed to be use related.A lot history review (lhr) of rebr1443 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported icu patient pulled on the picc and the center red lumen came off the extension leg.There was no patient harm reported.

• Brand Name: POWERPICC SOLO 5F, TL, TT, 3CG
• 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: 7498813
• Report Number: 3006260740-2018-00934
• Device Sequence Number: 13877521
• Product Code: LJS
• UDI-Device Identifier: 00801741139611
• UDI-Public: (01)00801741139611
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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 Catalogue Number: CK000079D
• Device Lot Number: REBR1443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1