MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer "i advanced the guide wire with no issues.Once i advanced the wings there was a pop sensation and the wings advanced.Upon removal of powerglide base, i noted no needle safety shield on the end of needle.Only guide wire and needle exposed.Upon opening base to ensure parts were left in patient, noted safety at base of needle." 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.
Event or Problem Description
It was reported by the customer "i advanced the guide wire with no issues.Once i advanced the wings there was a pop sensation and the wings advanced.Upon removal of powerglide base, i noted no needle safety shield on the end of needle.Only guide wire and needle exposed.Upon opening base to ensure parts were left in patient, noted safety at base of needle." no other information was provided.Additional information received on 6/12/2023: it was reported by the customer ¿the patient is over age 50.The event did not involve an urgent/life threatening medical situation, patient harm, injury, complication, or significant delay in treatment.¿.
Event or Problem Description
It was reported by the customer "i advanced the guide wire with no issues.Once i advanced the wings there was a pop sensation and the wings advanced.Upon removal of powerglide base, i noted no needle safety shield on the end of needle.Only guide wire and needle exposed.Upon opening base to ensure parts were left in patient, noted safety at base of needle." no other information was provided.Additional information received 6/12/2023: it was reported by the customer ¿the patient is over age 50.The event did not involve an urgent/life threatening medical situation, patient harm, injury, complication, or significant delay in treatment.¿.
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 complaint of a safety mechanism not activating is confirmed; however, the exact cause is unknown.One photograph and one video of a powerglide pro were returned for evaluation.An initial visual observation of the photograph and video showed pieces of the powerglide pro separated.The needle and safety mechanism were detached from the housing, and the safety mechanism was at the proximal end of the needle and the needle tip was exposed.The top housing portion of the device showed the guidewire connected to the coupler and the guidewire was pointing upward.The clear portion of the housing, the catheter, and the handle/wings could not be seen in the returned photograph and video.Some use residue was observed on the sample in the returned photograph.No obvious damage was observed.While the exact cause of the observed safety mechanism not activating could not be determined from the returned photograph, possible causes include detachment of safety mechanism from carrier during use/manipulation, damaged component, and misassembled device.

• Brand Name: FULL KIT 20G X 10 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17087626
• Report Number: 3006260740-2023-02352
• Device Sequence Number: 2773687
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2023

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F320108PT
• Device Lot Number: REHN2663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 09/07/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/07/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Hispanic