MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2021
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 reex1138 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "per mother ¿leaking from a hole in the re-enforced area of end of tubing where cap attaches¿ placed (b)(6) 2021 secured with statlock broke (b)(6) 2021 removed 4/12/2021 patient had to come into the hospital and get another picc line placed in ir.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 3fr s/l powerpicc provena.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a split was observed just distal of the strain-relief sleeve.Microscopic examination of the catheter split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: ¿ the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.Planar shape to the fracture surface.Blood residue was seen on the sample which showed that the product had undergone at least some use.The product ifu states ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.¿ an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "per mother ¿leaking from a hole in the re-enforced area of end of tubing where cap attaches¿ placed (b)(6) 2021.Secured with statlock.Broke (b)(6) 2021.Removed (b)(6) 2021.Patient had to come into the hospital and get another picc line placed in ir.

• Brand Name: PROV 3F SL IR 70CM 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: 11790978
• Report Number: 3006260740-2021-01748
• Device Sequence Number: 14410944
• Product Code: LJS
• UDI-Device Identifier: 00801741129971
• UDI-Public: (01)00801741129971
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: REEX1138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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
• Patient Age: 11 YR
• Patient Weight: 31