MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 3F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9173108D
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 reby1987 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a patient was re-admitted with a 3fr picc where the hub was almost completely separated from the extension leg.No other information was provided.
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 split is confirmed; however the cause is unknown.One 3 fr powerpicc sv was returned for investigation.The catheter extended up to the 34 cm depth marker.Use residue was observed throughout the device.A large split on the catheter was visible at the distal end of the of the luer hub.Microscopic observation of the break surface revealed rough, fissure-like patterns on the surface.The extension tubing did not appear to be uniformly attached to the luer connector near the break location.Based on the condition of the returned sample, possible contributing factors include material fatigue and tensile damage.A lot history review (lhr) of reby1987 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a patient was re-admitted with a 3fr picc where the hub was almost completely separated from the extension leg.No other information was provided.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 3F
• 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: 7450650
• Report Number: 3006260740-2018-00792
• Device Sequence Number: 13727454
• Product Code: LJS
• UDI-Device Identifier: 00801741035531
• UDI-Public: (01)00801741035531
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 9173108D
• Device Catalogue Number: 9173108D
• Device Lot Number: REBY1987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1