MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (70 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redz1944 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the wire, not the tip, got caught inside the needle and tore.No other information was provided.
Event or Problem Description
It was reported that the wire, not the tip, got caught inside the needle and tore.No other information was provided.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed, but the exact cause could not be determined from the three photographs that were provided for investigation.The photos showed the open packaging with part number 3194155 and lot #redz1944 on the label.An introducer needle with green hub was shown with a damaged guidewire within the needle.The wire appeared to be kinked at the needle bevel.The section of coil wire extending from the green hub appeared unraveled.The core wire appeared to be exposed from the unraveled coil wire.This type of damage can occur during use if the guidewire is retracted through the needle; however, the exact mechanism of damage could not be determined from the photographs.The product ifu cautions, ¿if the guidewire must be withdrawn while the needle is inserted, remove both needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) of redz1944 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (70 CM)
• 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: 10370939
• Report Number: 3006260740-2020-02777
• Device Sequence Number: 3094812
• Product Code: LJS
• UDI-Device Identifier: 00801741027765
• UDI-Public: (01)00801741027765
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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 Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 3194155
• Device Lot Number: REDZ1944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1