MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL; 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	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recz1365 showed no other similar product complaint(s) from this lot number.Device not yet returned.
Event or Problem Description
It was reported that the picc line was placed and started to leak immediately.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: sample evaluation, patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking picc was confirmed and the cause was determined to be use related.The product returned for evaluation was a 5fr t/l powerpicc catheter.The sampled contained usage residue throughout and needleless injection caps were attached to each luer cap.Gross visual evaluation of the device revealed the presence of a longitudinally-aligned split between the 1cm-3cm depth markings.The split measured 1.4cm in length and the fracture edges were finely formed and appeared as a fine line within the catheter.Microscopic examination of the split showed that each termination point of the split was tapered outwards which proved that the damage had originated exterior to the catheter.The fracture surfaces were planar in nature.Functional testing found that the catheter only leaked when infused through the gray-luered lumen.The short timeframe between the insertion date and the date of discovery suggests the damage likely occurred during insertion.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.
Event or Problem Description
It was reported that the picc line was placed and started to leak immediately.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: sample evaluation, patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking picc was confirmed and the cause was determined to be use related.The product returned for evaluation was a 5fr t/l powerpicc catheter.The sampled contained usage residue throughout and needleless injection caps were attached to each luer cap.Gross visual evaluation of the device revealed the presence of a longitudinally aligned split between the 1cm-3cm depth markings.The split measured 1.4cm in length and the fracture edges were finely formed and appeared as a fine line within the catheter.Microscopic examination of the split showed that each termination point of the split was tapered outwards which proved that the damage had originated exterior to the catheter.The fracture surfaces were planar in nature.Functional testing found that the catheter only leaked when infused through the gray-luered lumen.The short timeframe between the insertion date and the date of discovery suggests the damage likely occurred during insertion.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of recz1365 showed no other similar product complaint(s) from this lot number.Attachment: [(b)(4)_mw(b)(4).Pdf].
Event or Problem Description
It was reported that the picc line was placed and started to leak immediately.5/30/19- medwatch rec'd stated, "picc line has placed and started to leak immediately.".

• Brand Name: POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL
• 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: 8557768
• Report Number: 3006260740-2019-01204
• Device Sequence Number: 1852270
• Product Code: LJS
• UDI-Device Identifier: 00801741034640
• UDI-Public: (01)00801741034640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2019
• Report Date (Section F): 04/04/2019

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 Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 1385108Q
• Device Lot Number: RECZ1365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/16/2019; 05/30/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/22/2019; 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 68
• Date Report Sent to FDA: 04/04/2019