MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
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 that when removing safe step needle, the safety mechanism of the needle was not activated, causing the needle to separate from the base, resulting in a needle stick incident for nursing staff.Resulted in blood draw to monitor bloodstream infection.Additional information provided 2/22/2024: it was reported after needlestick, the nurse took blood tests, and everything was fine.
Event or Problem Description
It was reported that when removing safe step needle, the safety mechanism of the needle was not activated, causing the needle to separate from the base, resulting in a needle stick incident for nursing staff.Resulted in blood draw to monitor bloodstream infection.Additional information provided (b)(6) 2024: it was reported after needlestick, the nurse took blood tests, and everything was fine.
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 damaged safety mechanism is confirmed and was determined to be use related.The product returned for evaluation was a 20ga x 1¿ safestep infusion set.The safety plate was detached from the needle.Use residue was observed on the device.Microscopic inspection of the metal sleeve revealed the inner diameter was within range for a 20ga needle.Microscopic inspection and measurement of the angle of the needle revealed it was approximately 6 degrees.The angle of a non-complainant needle is approximately 14 degrees.The deformation of the needle was consistent with forceful activation of the safety likely during use.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN
• 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18815740
• Report Number: 3006260740-2024-00843
• Device Sequence Number: 4342841
• Product Code: FPA
• UDI-Device Identifier: 00801741066221
• UDI-Public: (01)00801741066221
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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: 09/07/2025
• Device Model Number: N/A
• Device Catalogue Number: LH-0032
• Device Lot Number: ASGWFC030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: Required Intervention
• Patient Sex: Unknown