MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PROV 3F SL IR 135CM NI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of reen1175 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reen1175) have been reported from the same facility.
Event or Problem Description
It was reported "the picc lines come manufactured with markings on the catheter.The markings represent a centimeter and a number is represented every 5th marking (ex.5, 10, 15 etc).It is documented in the patient¿s chart the length the catheter is measured and cut.We had to open and use two separate picc line packages for this patient because the markings were inaccurate.One catheter had the number 10 marked after 12 centimeter marks and the other catheter had the number 10 after 11 marks.This discrepancy makes it difficult to get an accurate measurement and can result in opening and using multiple picc catheter kits per patient.Also, for removal purposes the length should be accurate and correlate with the documented measurement to ensure no part of the catheter was retained during removal." this report addresses the catheter that had the number 10 marked after 11 centimeter mark.

• Brand Name: PROV 3F SL IR 135CM NI
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10942951
• Report Number: 3006260740-2020-20756
• Device Sequence Number: 13698652
• Product Code: LJS
• UDI-Device Identifier: 00801741129964
• UDI-Public: (01)00801741129964
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: S3173335
• Device Lot Number: REEN1175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other