MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROVENA PPICC, 4F DL, IR 70CM NI; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	S3274355
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebv0533 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the nurse went to flush the picc line per protocol.Upon flushing the lumen with the red hub, it was noted that the line was leaking directly below the red hub.Upon inspection, the nurse found a crack below the red hub.No harm to the patient 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 complaint of a tear in the extension leg was confirmed.One 4fr d/l powerpicc provena was returned for investigation.Evidence of use was observed on the sample.The printing on the extension legs was worn.Residue, which appeared to be from a dressing, was observed on the extension legs and bifurcation.Debris was observed on the clamps.A functional test revealed fluid leaking at the distal end of the red luer adaptor.A microscopic examination of the leak site revealed a tear in the extension leg within the distal end of the red luer adaptor that exposed the inner lumen of the catheter.The adjoining surfaces of the torn extension leg revealed a rough and jagged surface.A lot history review (lhr) of rebv0533 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the nurse went to flush the picc line per protocol.Upon flushing the lumen with the red hub, it was noted that the line was leaking directly below the red hub.Upon inspection, the nurse found a crack below the red hub.No harm to the patient 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 complaint of a tear in the extension leg was confirmed.One 4fr d/l powerpicc provena was returned for investigation.Evidence of use was observed on the sample.The printing on the extension legs was worn.Residue, which appeared to be from a dressing, was observed on the extension legs and bifurcation.Debris was observed on the clamps.A functional test revealed fluid leaking at the distal end of the red luer adaptor.A microscopic examination of the leak site revealed a tear in the extension leg within the distal end of the red luer adaptor that exposed the inner lumen of the catheter.The adjoining surfaces of the torn extension leg revealed a rough and jagged surface.A lot history review (lhr) of rebv0533 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the nurse went to flush the picc line per protocol.Upon flushing the lumen with the red hub, it was noted that the line was leaking directly below the red hub.Upon inspection, the nurse found a crack below the red hub.No harm to the patient was reported.

• Brand Name: PROVENA PPICC, 4F DL, IR 70CM NI
• 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: 7053885
• Report Number: 3006260740-2017-02101
• Device Sequence Number: 2144359
• Product Code: LJS
• UDI-Device Identifier: 00801741130052
• UDI-Public: (01)00801741130052
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2018

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 Catalogue Number: S3274355
• Device Lot Number: REBV0533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/11/2017; 12/28/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/18/2018; 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1