MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 6F; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
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 reaz0983 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that the catheter appears to have a crack at the hub.No other information was reported, but has been requested.
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 cracked luer connector was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was a 6fr t/l powerpicc solo catheter.The white solo connector cap was broken and a loose segment was also returned.The break in the connector was primarily oriented in the longitudinal direction.The luer threads of the pieces appeared normally formed and undamaged.Microscopic examination of the fracture surfaces found that they were rough and granular in nature and topographically complex.An additional crack in the attached luer was found which was also primarily oriented in the longitudinal direction.The sample was sent to the manufacturing facility for further review.
Event or Problem Description
Facility reported to the sales rep that the catheter appears to have a crack at the hub.No other information was reported, but has been requested.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 6F
• 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: 6817066
• Report Number: 3006260740-2017-01424
• Device Sequence Number: 16400493
• Product Code: LJS
• UDI-Device Identifier: 00801741034732
• UDI-Public: (01)00801741034732
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 12/28/2016
• Device Model Number: N/A
• Device Catalogue Number: 1396108
• Device Lot Number: REAZ0983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1