MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 detached needle was confirmed, but the exact cause of the damage could not be determined from the photograph that was provided for investigation.The photo showed a powerglide deployment system with what appeared to be the guidewire extending from the housing.The housing was shown with the guidewire push-off button in the extended position.The inside of the housing was not visible since the white cover of the housing was upright.The clear portion of the housing was facing downward away from the camera.The needle cannula was separated from the housing.The pink wings and safety mechanism were positioned at the proximal end of the needle cannula.Since the damage was observed in the photograph, the complaint was confirmed, but the physical condition and functional testing could not be evaluated without the physical sample.A lot history review (lhr) of reer1149 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "accessed vein like normal - deployed guidewire, felt stiff when pushing in - entire needle deployed into vessel.Went ahead and withdrew the needle out.Was able to save the catheter" additional information: "this was an (b)(6) being treated for a non-surgical arm fracture.She was a post code who eventually succumbed to her illness." (b)(6) 2021 the guidewire was found to be damaged and the needle cannula was detached from the housing.

• Brand Name: FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER
• 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: 11637850
• Report Number: 3006260740-2021-01198
• Device Sequence Number: 17058337
• Product Code: FOZ
• UDI-Device Identifier: 00801741140679
• UDI-Public: (01)00801741140679
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• 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): 03/29/2021

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: F320088PT
• Device Lot Number: REER1149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/08/2021
• 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: 83 YR