MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 5F NURSE FULL TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9295108
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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recs1200 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was very difficult to remove after an attempt to place it.It was stated once the physician had removed it, a knot in the catheter was noted.No additional information has been 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 knot in the picc was confirmed, and it appeared that the picc was damaged during use.One 5fr d/l powerpicc solo and tls stylet were returned for investigation.The catheter was received in two segments.The proximal segment consisted of the connectors, extension legs, bifurcation and the d/l tubing, which extended 1.5mm beyond the 36cm depth mark.An overhand knot was observed in the catheter at the 33cm depth mark.The distal segment of tubing was 17.6cm in length and contained the 38 through 54 cm depth marks.Biological residue was observed on the catheter at the 6cm depth mark.The stylet wire had been removed from the catheter.Multiple kinks and bends were observed in the stylet.A microscopic examination revealed that the polyimide tubing was broken near the distal end of the stylet and the distal tip was not returned for investigation.No portion of the stylet was found in the knotted section of the catheter.The polyimide tubing was stretched near the distal end of the core wire.The damage to the stylet was most likely a result of the damage to the catheter.The catheter may have inadvertently looped around and through itself within the vessel.Due to the condition of the returned sample, it was determined that the damage occurred during use.A lot history review (lhr) of recs1200 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was very difficult to remove after an attempt to place it.It was stated once the physician had removed it, a knot in the catheter was noted.No additional information has been reported.

• Brand Name: POWERPICC SOLO CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 5F NURSE FULL 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: 7794749
• Report Number: 3006260740-2018-02124
• Device Sequence Number: 11444777
• Product Code: LJS
• UDI-Device Identifier: 00801741028649
• UDI-Public: (01)00801741028649
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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: 9295108
• Device Catalogue Number: 9295108
• Device Lot Number: RECS1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1