MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recs2035 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the valved hub broke off of the extension leg on a picc.9/05/2019- additional information from facility stated, "patient was being moved in bed very little tension on iv tubing and the cap disconnected.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a separation of the hub from the extension leg tubing was confirmed and the damage appeared to be associated with use of the device.One red solo connector from a powerpicc was returned for investigation.A non-vad injection cap was attached to the connector.A 3.3cm segment of extension leg tubing was received separate from the connector.The remainder of the extension leg and powerpicc were not returned for investigation.The extension leg segment exhibits narrowing of the tubing distal to the segment that was attached to the hub.The outside diameter of the narrowed section of tubing was below the specification limit of the extension leg tubing.The extension leg completely separated from the solo connector.Due to the characteristics of the returned sample and plastic deformation of the extension set tubing, it appeared that the damage was a result of significant tensile stress during use.It was reported that the patient was being moved in bed when the hub detached from the extension leg.A lot history review (lhr) of recs2035 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the valved hub broke off of the extension leg on a picc.On 9/05/2019 - additional information from facility stated, "patient was being moved in bed very little tension on iv tubing and the cap disconnected.".

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT
• 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: 9035890
• Report Number: 3006260740-2019-02695
• Device Sequence Number: 1743542
• Product Code: LJS
• UDI-Device Identifier: 00801741154812
• UDI-Public: (01)00801741154812
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: S1395108D1
• Device Lot Number: RECS2035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 78