MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SECURELOC SAFETY INTRODUCER NEEDLE 21G X 2.75 IN; INTRODUCER, CATHETER

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	04/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "green safety mechanism broke off of the needle" no other information was provided.
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Additional Manufacturer Narrative
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of safety mechanism detachment was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one safety barrel from a 21ga safety introducer needle.The safety was completely detached from the needle, which was not returned.Microscopic inspection of the safety mechanism revealed it to be well-formed and unremarkable.The safety mechanism was disassembled, and properly assembled over a non-complainant needle shaft.The safety subsequently functioned as intended, securing the needle tip upon advancement.The safety mechanism components appeared well formed and functioned as intended when assembled with a non-complainant needle.These observations suggested that the safety mechanism detachment was likely caused by improper initially assembly of the needle/safety barrel.Photographs have been forwarded to the manufacturing site for further evaluation.
Event or Problem Description
It was reported by the customer that "green safety mechanism broke off of the needle" no other information was provided.

• Brand Name: SECURELOC SAFETY INTRODUCER NEEDLE 21G X 2.75 IN
• Common Device Name: INTRODUCER, CATHETER
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16935823
• Report Number: 3006260740-2023-01907
• Device Sequence Number: 5730491
• Product Code: DYB
• UDI-Device Identifier: 00801741041716
• UDI-Public: (01)00801741041716
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050023
• 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): 11/28/2023

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 Model Number: N/A
• Device Catalogue Number: S03021-275
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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