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

Catalog Number	CK000688
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebv2361 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the catheter is leaking at the hub; a hole was allegedly found near the hub of the purple port.No patient injury 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 leak in the catheter was confirmed, and the damage appeared to be use related.One 5fr d/l powerpicc solo was returned for investigation.The catheter extended to the 38cm depth mark, where it had been trimmed to length.A sticky residue was observed on the extension legs, which is consistent with tape residue.A functional test revealed a leak in the extension leg with the purple luer adaptor just distal to the bifurcation.A microscopic examination revealed a symmetric pattern around the d/l tubing, which is consistent with the tubing being grasped with a sharp instrument such as forceps.Two holes were observed on opposite sides of the tubing just distal to the bifurcation.The product ifu states, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.¿ due to the evidence of use observed on the returned sample, it appeared that the catheter was damaged after placement.A lot history review (lhr) of rebv2361 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the catheter is leaking at the hub; a hole was allegedly found near the hub of the purple port.No patient injury reported.

• Brand Name: POWERPICC SOLO CATHETER, 5 F DL, 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: 7289847
• Report Number: 3006260740-2018-00258
• Device Sequence Number: 16456389
• Product Code: LJS
• UDI-Device Identifier: 00801741136542
• UDI-Public: (01)00801741136542
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: CK000688
• Device Lot Number: REBV2361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Event Location: Home
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1