MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER 3F FULL TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3173108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the picc was placed in the cath lab on (b)(6) 2018.It was stated that the picc broke/tore externally by the hub on (b)(6) 2018.The catheter was removed and replaced.The patient had to be transported to or and undergo anesthesia in order to have the picc replaced due to his complex cardiac condition.
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 split near the hub is confirmed; however, the exact cause is unknown.One 3 fr single lumen powerpicc sv was returned for evaluation.An initial visual observation showed a large amount of blood residue within the extension leg.A split was observed in the extension tubing just within the distal end of the luer connector hub.The ink on the extension tubing was observed to be worn and faded.The sample was flushed with a 12 ml syringe of water and a leak was observed emanating from the split in the extension tubing.A microscopic observation revealed the fracture surface of the split was rough and exhibited cracks/fissures and beach marks, which are typical of material fatigue; however the exact cause of the split is unknown at this time, and could not be confirmed as a deficiency in product manufacture or a deficiency while under correct product use.Possible contributing factors include material fatigue and mishandling by patient or clinician.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the picc was placed in the cath lab on (b)(6) 2018.It was stated that the picc broke/tore externally by the hub on (b)(6) 2018.The catheter was removed and replaced.The patient had to be transported to operating room and undergo anesthesia in order to have the picc replaced due to his complex cardiac condition.

• Brand Name: POWERPICC SV CATHETER 3F FULL TRAY (SINGLE-LUMEN)
• 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: 7807701
• Report Number: 3006260740-2018-02183
• Device Sequence Number: 11141396
• Product Code: LJS
• UDI-Device Identifier: 00801741027529
• UDI-Public: (01)00801741027529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 3173108
• Device Catalogue Number: 3173108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 MO