MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
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 was inconclusive because no sample was returned for evaluation.Based on the description of the reported event, possible contributing factors include sharp instrument contact, tensile damage and material fatigue; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of recu2204 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after what appeared to be a successful insertion, the picc was flushed and aspirated, when they noticed a lot of air bubbles in the syringe (likely indicating an air leak or hole somewhere in the line).They opened a new kit, replaced the catheter and it was stated everything functioned normally with the second device.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI
• 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: 8028461
• Report Number: 3006260740-2018-03063
• Device Sequence Number: 1303189
• Product Code: LJS
• UDI-Device Identifier: 00801741035760
• UDI-Public: (01)00801741035760
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: N/A
• Device Catalogue Number: 9295108D
• Device Lot Number: RECU2204
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1