MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rect2480 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that picc line was inserted, rn went to flush the red lumen and noticed leaking from the hub.Picc was removed due to the leaking and a new one was placed.No patient harm was reported.
Event or Problem Description
It was reported that picc line was inserted, rn went to flush the red lumen and noticed leaking from the hub.Picc was removed due to the leaking and a new one was placed.No patient harm was 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 is confirmed; however the root cause is unknown.One5 fr dual lumen powerpicc solo was returned for evaluation.An initial visual observation showed some use residue on the returned sample and a clear fluid was observed in the extension legs.Needleless injection caps were observed on both luer connectors.Both lumens were flushed with a 12 ml syringe of water and a spraying leak was observed emanating from the red luer hub.A microscopic observation revealed a large longitudinal crack in the luer hub of the red lumen.The fracture surface of the crack was observed to be rough and uneven, but no voids were observed in the material.Some mechanical damage was observed on the proximal end of one of the luer threads of the red lumen.While the cause of the crack in the luer hub is unknown, possible contributing factors include over-tightening of connectors onto the luer hub and chemical exposure.An examination of the returned sample revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of rect2480 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 8416533
• Report Number: 3006260740-2019-00543
• Device Sequence Number: 2170272
• Product Code: LJS
• UDI-Device Identifier: 00801741096280
• UDI-Public: (01)00801741096280
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: N/A
• Device Catalogue Number: CK000409
• Device Lot Number: RECT2480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1