MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Model Number	383336
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: initial reporter phone #: (b)(4).Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that 2 of the bd saf-t-intima¿ iv catheter safety system cannot be withdrawn.The following information was provided by the initial reporter, translated from chinese to english: after injection, the needle cannot be withdrawn.
Event or Problem Description
It was reported by the customer that 2 of the bd saf-t-intima¿ iv catheter safety system cannot be withdrawn.The following information was provided by the initial reporter, translated from chinese to english: after injection, the needle cannot be withdrawn.
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of needle disengagement difficult was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample or lot number was returned for evaluation.A device history review could not be completed as no batch number was provided.H3 other text: see h10.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15813095
• Report Number: 3014704491-2022-00581
• Device Sequence Number: 20165650
• Product Code: FOZ
• UDI-Device Identifier: 30382903833369
• UDI-Public: (01)30382903833369
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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 Model Number: 383336
• Device Catalogue Number: 383336
• Device Lot Number: UNKNOWN
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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