MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383346
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.Device expiration date: unknown.Device manufacture date: unknown.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 that a bd saf-t-intima¿ iv catheter safety system had a needle that failed to retract, causing it to puncture the tubing and stick an employee.No medical intervention was reported.
Additional Manufacturer Narrative
Unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.However a sample was submitted for evaluation, the returned sample had the slide clamp applied to the tubing of the device.The reported needle stick and needle retraction failure were confirmed after evaluate the sample received.Bd engineers were able to successfully retract the needle after the removal of the slide clamp from the tubing.At this time, bd is unable to determine a root because that is associated with our manufacturing process.Because the device was successfully activated during the course of our investigation, it was determined that a possible cause for the reported failure mode is related to the procedure implemented during use of the product.
Event or Problem Description
It was reported that a bd saf-t-intima iv catheter safety system had a needle that failed to retract, causing it to puncture the tubing and stick an employee.No medical intervention was reported.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• 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
• MDR Report Key: 7881808
• Report Number: 9610847-2018-00304
• Device Sequence Number: 2365591
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (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): 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 383346
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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