MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 6F MAXIMAL BARRIER TRAY; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	1396108D
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebv1547 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the facility reported that the picc line began to leak from the hub.It was noted that the hub was cracked.The picc was removed and replaced.No reported patient injury.
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 crack in the gray connector was confirmed, and was considered manufacturing related.The implicated and returned product was a 6fr triple-lumen powerpicc solo.The gray connector was cracked and a 1mm x 0.5mm portion of the thread broke away and was not returned for investigation.The valve was still held in place.Cavity ¿o¿ was identified on the gray connector.No cracks were observed on the other connectors.The red and white connectors were molded in cavity ¿o¿ and ¿j¿, respectively.A microscopic examination revealed that the crack had sharp edges and no plastic deformation was observed.A lot history review (lhr) of rebv1547 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc line began to leak from the hub.It was noted that the hub was cracked.The picc was removed and replaced.No reported patient injury.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 6F MAXIMAL BARRIER TRAY
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7050376
• Report Number: 3006260740-2017-02092
• Device Sequence Number: 903266
• Product Code: LJS
• UDI-Device Identifier: 00801741034749
• UDI-Public: (01)00801741034749
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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: 1396108D
• Device Catalogue Number: 1396108D
• Device Lot Number: REBV1547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1