MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I; INTRAVASCULAR CATHETER

Catalog Number	383313
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd saf-t-intima bent in half.The following information was provided by the initial reporter: bd saf-t-intima had a defective catheter.Attempted to advance into vein, great blood flow but the plastic bent in half.Still had saline and blood flow in and out but didn't trust that it would not cause contamination of the radiotracer i needed to inject.Set new line for injection.
Event or Problem Description
No additional information was provided item#383313 lot#3171205.
Additional Manufacturer Narrative
Dhr review: the complaint lot# is 3171205, sku is 383313, assembly in suzhou plant on 2023.Jun.26, lot quantity is 24066ea 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 returned sample analysis: no returned sample was sent back, no photos provided retain sample analysis: sampling 2ea from the retain sample of the same lot to check needle and catheter assembly status, check lie distance, all test results are within product specification.Refer to the attachment for retain sample test report.Possible cause analysis: based on the reported information, lie distance is incorrect.Possible reasons for this type of failure may including: 1.Lie distance setting is not correct during assembly 2.Lie distance is changed during the following manual assembly flow or manual packaging after lie distance precise setting current manufacture already has control procedures as below to detect and prevent this kind of defect: 1.100% inspection for lie distance during all process station after lie distance precise setting 2.Both in-process and outgoing sampling check will inspect lie distance there is no defect sample returned, no photos provided as well, the retain sample check results are all within product specifications.With the described information we cannot identify the root cause for this case.

• Brand Name: BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• 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: 18567950
• Report Number: 3014704491-2024-00031
• Device Sequence Number: 12891021
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: (01)30382903833130
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K923702
• 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): 02/28/2024

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 Catalogue Number: 383313
• Device Lot Number: 3171205
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown