MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number	383336
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 while using bd saf-t-intima¿ closed iv catheter system it was damaged and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: regarding broken saf-t-intima items today.Item# 383336.Additional information received 29-nov-2022: do you know the date of event? (b)(6) 2022, (b)(6) 2022, and (b)(6) 2022.Do you know that lot number? no i don't know the lot number for the first 2 incidents.The third was lot #1287217 was there any patient impact or harm due to the reported issue? if so please advise if there was a need for any medical treatment or intervention needed.Yes, the first 2 incidents caused chemo spills with significant clean up.
Event or Problem Description
It was reported while using bd saf-t-intima¿ closed iv catheter system it was damaged and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: regarding broken saf-t-intima items today.Item# 383336.Additional information received 29-nov-2022 ¿ do you know the date of event? 11/7/22, 11/15/22, and 11/21/22 ¿ do you know that lot number? no i don't know the lot number for the first 2 incidents.The third was lot #1287217.¿ was there any patient impact or harm due to the reported issue? if so please advise if there was a need for any medical treatment or intervention needed.Yes, the first 2 incidents caused chemo spills with significant clean up.
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of adapter / connector defective / damaged was confirmed upon inspection of the photo.Analysis of the sample showed that the sample in the photo was missing threading on the adapter.The reported issue of leakage was confirmed upon inspection of the photo.Analysis of the sample showed that the sample in the photo was missing threading on the adapter, which would result in a failed connection and leakage.Bd determined that the cause of the failure was related to a molding error in our supplier¿s process.No dhr review was performed since the customer did not provide a batch number to report.H3 other text : see h10.

• Brand Name: BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15970445
• Report Number: 1710034-2022-00796
• Device Sequence Number: 12156045
• Product Code: FOZ
• UDI-Device Identifier: 30382903833369
• UDI-Public: (01)30382903833369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 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: 11/17/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/07/2023
• 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