MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR TL POWERPICC SOLO NURSE FULL WITH MI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3396108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebr0557 showed one other similar product complaints from this lot number.Device not returned, at this time.
Event or Problem Description
It was reported by the facility that the line was successfully inserted without issue, however the following day the white port on the 6fr triple lumen was cracked down the hub.No patient injury was reported.
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 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 appeared to be manufacturing related.The product returned for evaluation was a 6fr t/l powerpicc solo catheter.The white solo connector cap contained a break within the luer threads and broken pieces were found within the male luer connector of a returned injection cap.Microscopic examination of the fracture surfaces showed that they were rough and granular in nature.The sample was sent to the manufacturing facility for further review.Manufacturing evaluation the complaint for ¿valve cracked¿ is confirmed according the evaluation of the sample received which showed an inconsistency in the molding valve.The manufacturer will continue to monitor and trend for this issue.
Event or Problem Description
It was reported by the facility that the line was successfully inserted without issue, however the following day the white port on the 6fr triple lumen was cracked down the hub.No patient injury was reported.

• Brand Name: 6 FR TL POWERPICC SOLO NURSE FULL WITH MI
• 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: 6802566
• Report Number: 3006260740-2017-01338
• Device Sequence Number: 162424
• Product Code: LJS
• UDI-Device Identifier: 00801741028397
• UDI-Public: (01)00801741028397
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: 09/30/2018
• Device Model Number: 3396108
• Device Catalogue Number: 3396108
• Device Lot Number: REBR0557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1