MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that ¿one of my vascular access nurses was in the middle of a procedure when he stuck himself by reaching onto the tray.He had just removed the needle from the catheter and the safety did not engage." 11/8/2023: it was reported the patient was admitted with n/v.The event didn't involve an urgent or life-threatening medical situation or delays in treatment.No adverse event other than the employee being stuck with a dirty needle.The treatment was completed with line insertion and there was no change in care.11/14/2023: it was reported by the customer "labs were drawn, patient does not have any blood-borne diseases that we are aware of.Event was reported to facility employee health.Labs drawn on the clinician for baseline and we followed our post needle stick policy.".
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 device has not been returned to the manufacturer for evaluation.
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 safety did not activate for an introducer needle is confirmed but the root cause could not be determined.One 21 ga bbraun safecan introducer needle was returned for evaluation.An initial visual observation showed use residues throughout the returned introducer needle.The safety mechanism was observed to not be engaged, but the safecan that slides over the metal safety mechanism was missing from the returned device.The metal safety mechanism was found halfway down the needle shaft.A functional test of attempting to slide the metal safety mechanism down the needle shaft and over the needle tip revealed the safety mechanism to slide down over the needle tip without resistance.A microscopic observation revealed the tip of the safety mechanism to be slightly deformed.Because the device was returned opened and used without the safecan, the complaint of a safety mechanism not activating correctly is confirmed but the exact cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings in section h:11.
Event or Problem Description
It was reported by customer that ¿one of my vascular access nurses was in the middle of a procedure when he stuck himself by reaching onto the tray.He had just removed the needle from the catheter and the safety did not engage." 11/8/2023: it was reported the patient was admitted with n/v.The event didn't involve an urgent or life-threatening medical situation or delays in treatment.No adverse event other than the employee being stuck with a dirty needle.The treatment was completed with line insertion and there was no change in care.(b)(6) 2023: it was reported by the customer "labs were drawn, patient does not have any blood-borne diseases that we are aware of.Event was reported to facility employee health.Labs drawn on the clinician for baseline and we followed our post needle stick policy.".

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: 18193936
• Report Number: 3006260740-2023-05305
• Device Sequence Number: 12710317
• Product Code: LJS
• UDI-Device Identifier: 00801741154744
• UDI-Public: (01)00801741154744
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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
• Report Date (Section B): 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D1
• Device Lot Number: REHU3009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male