MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 19G X 25MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the needle guard came loose when the port was pulled out and the employee pricked herself superficially.Immediate action taken by the hospital / caretaker relevant to the care of the patient.Wound disinfected and needle separated.The incident happened after use on a patient.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 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 detachment of the needle safety is confirmed and was determined to be manufacturing related.The product returned for evaluation was a powerloc ez infusion set.The needle housing and bio-bag safety mechanism were returned separated.Use residue was observed on the device.Microscopic inspection of the bio-bag safety mechanism revealed the seal on the distal end of the bag had opened.Microscopic inspection of the needle bevel revealed evidence of use but no damage was observed.The open seal on the bio-bag safety mechanism was caused by detachment of the biobag, likely due to the manufacture of the device.The investigation has been forwarded to the manufacturing site for further investigation.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 that the needle guard came loose when the port was pulled out and the employee pricked herself superficially.Immediate action taken by the hospital / caretaker relevant to the care of the patient.Wound disinfected and needle separated.The incident happened after use on a patient.No other information was provided.

• Brand Name: EZ HUBER 19G X 25MM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18271575
• Report Number: 3006260740-2023-05513
• Device Sequence Number: 4007107
• Product Code: FPA
• UDI-Device Identifier: 00801741089077
• UDI-Public: (01)00801741089077
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: SHG19-100
• Device Lot Number: REGV1206
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: Unknown