MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	383346
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
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 w/y adapter gn 18ga x 1.0in needle pulled out of the hub.The following information was provided by the initial reporter; during the puncture of a tomography patient, where he was going to undergo a heart tomography, the metal part of the needle came off, but it was possible to remove the metal needle without causing harm to the patient.
Additional Manufacturer Narrative
Dhr review: the complaint lot#2235004 sku is 383346, assembly in suzhou plant1 on 2022.Sep.24, lot quantity is (b)(4).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 return sample analysis: no defect sample returned, no picture provided retain sample analysis: sampling 2 ea from the retain sample of the same lot to check needle assembly status and retraction function, test result is good.Refer to the attachment for retain sample test report possible cause analysis: the complaint reports that needle is not withdrawn together with guide wire, the possible cause of this defect is that crimping condition between stylet and needle is not good.Current manufacture process have control procedures as below to protect this kind of possible cause: 1.After stylet/needle crimping process, 100% inspection is performed for the crimping status 2.Check the pull force between stylet(guide wire) and needle at the beginning of each shift 3.Qc in-process sampling check the pull force above, and sampling check the finish goods after eo for this item as well.As conclusion, there is no sample returned, no picture of the defect sample provided, we cannot clarify the actual defect feature.Sampling check the retained sample, all related items are within product specification, so the root cause is not clear.
Event or Problem Description
No additional information provided.

• Brand Name: BD SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN
• 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: 18144762
• Report Number: 3014704491-2023-00734
• Device Sequence Number: 6987997
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: (01)30382903833468
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K923702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: Other
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 383346
• Device Lot Number: 2235004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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
• Patient Sex: Unknown