MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 4FR DL PROVENA MIDLINE MAX BARRIER KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	S4254108BDP
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reew1908 showed no other similar product complaint(s) from this lot number.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported the external purple lumen came out of the y or wings of the catheter, clean, full catheter without shards or tearing; empty hole leaking noted from primary rn.Catheter was trimmed to 18 cm with 1 cm out, placed with ease in the basilic vessel, and secured with statlock.
Event or Problem Description
It was reported "so wit was reported the external purple lumen came out of the y or wings of the catheter, clean, full catheter without shards or tearing; empty hole leaking noted from primary rn.Catheter was trimmed to 18 cm with 1 cm out, placed with ease in the basilic vessel, and secured with statlock.
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, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed but the exact cause remains unknown.Three photo samples of a 4 fr dl provena midline catheter were provided for evaluation.The first photo shows the extension tubing of a powermidline catheter within one of the ends covered in gauze.No apparent damage can be clearly observed on the extension tubing.The next two photo shows the purple luer hub and extension tubing.The distal end of the extension tubing is shown.The surface characteristics are not clearly visible; however, the surface appears to be even and flat.Based on the photo samples provided, possible contributing factors include tensile damage, sharp instrument damage, and material fatigue caused by repeated kinking.Since the extension leg was observed to be detached, the complaint is confirmed but the exact cause remains unknown.

• Brand Name: 4FR DL PROVENA MIDLINE MAX BARRIER KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11313752
• Report Number: 3006260740-2021-00319
• Device Sequence Number: 10941476
• Product Code: PND
• UDI-Device Identifier: 00801741154164
• UDI-Public: (01)00801741154164
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• 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): 03/24/2021

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: S4254108BDP
• Device Catalogue Number: S4254108BDP
• Device Lot Number: REEW1908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 04/22/2021
• 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