MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 18 GA 1.00 IN; INTRAVASCULAR CATHETER

Model Number	383346
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that bd saf-t-intima¿ safety system with y adapter 18 ga 1.00 in leaked.The following information was provided by the initial reporter: "after the successful use of winma puncture in the delivery room on july 24th, it was found that there was a leakage at the joint part between the extension tube and the green y-shaped base during the fluid infusion, and the indwelling needle was immediately removed".
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 9057759 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one picture sample was returned for evaluation by our quality engineer team.Through examination of the picture, leakage was observed between the tubing and the adapter assembly.Unfortunately, the damage responsible for the leakage could not be identified through the image provided.Our engineering and manufacturing team performed an inspection of the assembly process with the intention of finding a potential source for this issue, however, a source could not be found.
Event or Problem Description
It was reported that bd saf-t-intima¿ safety system with y adapter 18 ga 1.00 in leaked.The following information was provided by the initial reporter: "after the successful use of winma puncture in the delivery room on (b)(6), it was found that there was a leakage at the joint part between the extension tube and the green y-shaped base during the fluid infusion, and the indwelling needle was immediately removed".

• Brand Name: BD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 18 GA 1.00 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10411619
• Report Number: 9610847-2020-00243
• Device Sequence Number: 16742095
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 02/28/2023
• Device Model Number: 383346
• Device Catalogue Number: 383346
• Device Lot Number: 9057759
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other