MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	383346
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
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 saf-t-intima w/y adapter gn 18ga x 1.0in safety mechanism was difficult to disengage on 25 occasions.This caused a needle stick injury for the nurse.The following information was provided by the initial reporter: the indwelling needle was always punctured in the ward before the surgery in the hospital.On today's morning, when the nurse used 18g pegasus to do the puncturing, she found the needle was difficult to disengage after successful delivering.Nurse didn't want to do the puncturing again since she saw lots of blood in the extension tube, so she wanted to close the clamp.When nurse was closing the clamp, she was injured by the half- withdrawn needle.Patient was confirmed with hbv, and nurse was injected the vaccine and waiting the examined report.The head nurse and the injured nurse were anxiety, they wanted a full research and the result of this batch, and they didn't want to see this thing again.Since this was a serious incident, it had been reported to the equipment department with the needle stick injury process.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was completed for provided lot number 9122995.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this incident, a representative sample was returned for evaluation by our quality engineer team.The sample was functionally tested to measure the pull force of the inserter, the rubber cap, and the cover force.All of the test results were within specification.Based on the investigation results, an exact cause related to the manufacturing process could not be determined of this incident.(b)(4) see h.10.
Event or Problem Description
It was reported that saf-t-intima w/y adapter gn 18ga x 1.0in safety mechanism was difficult to disengage on 25 occasions.This caused a needle stick injury for the nurse.The following information was provided by the initial reporter: the indwelling needle was always punctured in the ward before the surgery in the hospital.On today's morning, when the nurse used 18g pegasus to do the puncturing, she found the needle was difficult to disengage after successful delivering.Nurse didn't want to do the puncturing again since she saw lots of blood in the extension tube, so she wanted to close the clamp.When nurse was closing the clamp, she was injured by the half- withdrawn needle.Patient was confirmed with hbv, and nurse was injected the vaccine and waiting the examined report.The head nurse and the injured nurse were anxiety, they wanted a full research and the result of this batch, and they didn't want to see this thing again.Since this was a serious incident, it had been reported to the equipment department with the needle stick injury process.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN
• 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: 11168035
• Report Number: 9610847-2021-00010
• Device Sequence Number: 3718200
• Product Code: FOZ
• UDI-Device Identifier: 00382903833467
• UDI-Public: 00382903833467
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/10/2021

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 383346
• Device Lot Number: 9122995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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