MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1295118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2017
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 rebr0714 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2017 a picc line sited in the patients right brachial vein, was noted to be leaking from the red lumen when being flushed with sterile saline pre-treatment.The skin under the dressing was intact and no phlebitis was present.A tear was visible in the line, on inspection.A replacement picc insertion was arranged before further treatment could be administered.The faulty line was inserted on (b)(6) 2017, only a few days prior to the fracture appearing (mark at skin 17cm, distance to hub 27cm).A replacement line was placed using over the wire technique (b)(6) 2017.There was no reported patient injury.
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 from the lumen with the red connector was confirmed, and the damage was determined to be use related.One 5fr d/l powerpicc solo was returned for investigation.The catheter had been trimmed to length 42.8cm from the distal end of the bifurcation.A functional test revealed a leak in the d/l tubing 5mm distal to the bifurcation.A slit was observed in the d/l tubing and the adjoining surfaces were glossy and striated, which is indicative of sharp instrument damage.Sharp edges were observed along the outside surface of the slit, which is also consistent with sharp instrument damage.The product ifu states, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.¿ a lot history review (lhr) of rebr0714 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2017 a picc line sited in the patients right brachial vein, was noted to be leaking from the red lumen when being flushed with sterile saline pre-treatment.The skin under the dressing was intact and no phlebitis was present.A tear was visible in the line, on inspection.A replacement picc insertion was arranged before further treatment could be administered.The faulty line was inserted on (b)(6) 2017, only a few days prior to the fracture appearing (mark at skin 17cm, distance to hub 27cm).A replacement line was placed using over the wire technique (b)(6) 2017.There was no reported patient injury.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F BASIC TRAY
• 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: 7184133
• Report Number: 3006260740-2017-02415
• Device Sequence Number: 73149
• Product Code: LJS
• UDI-Device Identifier: 00801741034633
• UDI-Public: (01)00801741034633
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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: 1295118
• Device Catalogue Number: 1295118
• Device Lot Number: REBR0714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1