MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROVENA PPICC, 3F SL, IR 70CM NI; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	S3173355
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2017
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 rebq2586 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (rebq2586) have been reported from the same facility.
Event or Problem Description
Facility reported to sales rep that they had a catheter fray near the hub.No other information was provided.No patient harm 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 break is confirmed; however the cause is unknown and an internal investigation is currently ongoing to determine the root cause.One 3 fr single lumen provena powerpicc was returned for evaluation.An initial visual observation showed the luer connector hub was detached completely from the extension leg, and a piece of the extension tubing was observed to remain within the hub.Use residue was observed on the returned sample.A microscopic observation revealed both fracture surfaces were rough and exhibited cracks and beach marks, which are indicative of material fatigue.The tubing material was observed to be attached to the luer connector at irregular points along the tubing¿s circumference, and cracking appeared to have initiated at one or more of these points.An internal investigation is currently ongoing to determine the root cause of this cracking a lot history review (lhr) of rebq2586 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (rebq2586) have been reported from the same facility.
Event or Problem Description
Facility reported to sales rep that they had a catheter fray near the hub.No other information was provided.No patient harm 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 break is confirmed; however the cause is unknown and an internal investigation is currently ongoing to determine the root cause.One 3 fr single lumen provena powerpicc was returned for evaluation.An initial visual observation showed the luer connector hub was detached completely from the extension leg, and a piece of the extension tubing was observed to remain within the hub.Use residue was observed on the returned sample.A microscopic observation revealed both fracture surfaces were rough and exhibited cracks and beach marks, which are indicative of material fatigue.The tubing material was observed to be attached to the luer connector at irregular points along the tubing¿s circumference, and cracking appeared to have initiated at one or more of these points.An internal investigation is currently ongoing to determine the root cause of this cracking a lot history review (lhr) of rebq2586 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (rebq2586) have been reported from the same facility.
Event or Problem Description
Facility reported to sales rep that they had a catheter fray near the hub.No other information was provided.No patient harm reported.

• Brand Name: PROVENA PPICC, 3F SL, 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: 6850038
• Report Number: 3006260740-2017-01578
• Device Sequence Number: 19111861
• Product Code: LJS
• UDI-Device Identifier: 00801741129971
• UDI-Public: (01)00801741129971
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• 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: S3173355
• Device Lot Number: REBQ2586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 09/28/2017; 12/28/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 10/31/2017; 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1