MAUDE Adverse Event Report: BECTON DICKINSON SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN; INTRAVASCULAR CATHETER

Catalog Number	383323
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field as the date of the event is unknown.
Event or Problem Description
It was reported that bd saf-t-intima w/y adapter bl 22ga x.75in - safety shield activation failure.Verbatim: rcc received a complaint via email.Started an iv with a 22g needle.When pulling back needle, safety mechanism did not engage.
Additional Manufacturer Narrative
Additional information: (b) date of event has since been provided.(h) attached medsun report; added report number.Investigation results: review the in-process test record and outgoing test report, all test results meet the product specifications, no abnormal found.Review the product assembly record, no non-conformities, deviations, or rework activities for this lot.Sampling 2ea from the retain sample of the same lot to check product function, product safety shield activation function is good.Possible cause analysis: based on the reported information, needle is exposure to air.Possible reasons for this type of failure may including: 1.The assembly status between outer shield and rubber is not good, the rubber is not pressed to the end during assembly 2.Product safety shield is pulled during manual assembly flow or manual packaging.Thess risk will cause the outer shield drops off before the needle retracted completely.Current manufacture already has control procedures as below to defect and prevent this kind of defect: 1.100% inspection for the gap between outer and rubber is performed at the last station of assembly 2.Both in-process and outgoing sampling check will test the separation force between rubber and outer shield we cannot identify the actual defect feature, cannot determine whether it¿s a poor assembly issue or raw material issue, so the root cause of this case is not clear.
Event or Problem Description
No additional information.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22829092
• Report Number: 3006948883-2025-00490
• Device Sequence Number: 4553167
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(17)280930(10)4262669
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• 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): 11/13/2025

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 Catalogue Number: 383323
• Device Lot Number: 4262669
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown