MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 4FR SL PWERML; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
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 reeq1272 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "i was placing a ml and after cannulating the vein with the stylus needle and getting blood return, the guidewire would not pass thru the hub of the stylus.I had to abort and stick the patient a second time with the angiocath in the kit.The wire passed without incident and the line was placed successfully.After the procedure i went back to the stylus and tried several things trying to thread the wire thru it.I believe there was a burr or lip of metal at the hub that obstructed the passage of the wire.¿ it was reported the device was discarded.Add info rcvd 05/11/2021: date of occurrence: 05/07/2021 placement info: n/a.Was there patient harm reported?: no.

• Brand Name: DOT 4FR SL PWERML
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11931556
• Report Number: 3006260740-2021-02136
• Device Sequence Number: 4491269
• Product Code: PND
• UDI-Device Identifier: 00801741185199
• UDI-Public: (01)00801741185199
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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: PP4154108DGPX
• Device Lot Number: REEQ1272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/03/2021
• 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