MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROV 3F SL IR 70CM NI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebw1532 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the hub broke off of the catheter.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed, and corrective action has been taken regarding failures of this type.One 3 fr single lumen powerpicc provena catheter was returned for evaluation.An initial visual observation showed use residue throughout the sample and the ink on the extension leg and molded joint was observed to be worn and faded.A large split was observed in the extension tubing just within the distal end of the luer connector.A microscopic observation revealed the fracture surface of the split in the extension tubing of the purple lumen was rough and exhibited cracks/fissures and beach marks.A lot history review (lhr) of rebw1532 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the hub broke off of the catheter.No other information was provided.

• Brand Name: PROV 3F SL IR 70CM NI
• 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: 9257057
• Report Number: 3006260740-2019-03396
• Device Sequence Number: 2054391
• Product Code: LJS
• UDI-Device Identifier: 00801741129971
• UDI-Public: (01)00801741129971
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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 Health Care Professional
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: S3173355
• Device Lot Number: REBW1532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1