MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I; INTRAVASCULAR CATHETER

Catalog Number 383313

Device Problem Break (1069)

Patient Problem Local Reaction (2035)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that saf-t-intima w/y adapter yel 24ga x.75i needle broke.The following information was provided by the initial reporter: this is catheter for subcutaneous or intravenous use.The integrated guidewire is withdrawn and contained within the safety mechanism and then discarded once the device is inserted, leaving a flexible cannula under the skin.In this incident (subcutaneous use), a small part of the guidewire broke off, remained inside the plastic cannula and was not immediately visible/known to be retained on insertion.The patient developed some redness and swelling around the site and when the cannula was removed approx.12 hours later, the retained guidewire was noted and caused a needlestick injury to the nurse removing the device.

Manufacturer Narrative

H6: investigation summary: a device history record review was completed by our quality engineer team for provided lot number 0065730.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.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

Event Description

It was reported that saf-t-intima w/y adapter yel 24ga x.75i needle broke.The following information was provided by the initial reporter: this is catheter for subcutaneous or intravenous use.The integrated guidewire is withdrawn and contained within the safety mechanism and then discarded once the device is inserted, leaving a flexible cannula under the skin.In this incident (subcutaneous use), a small part of the guidewire broke off, remained inside the plastic cannula and was not immediately visible/known to be retained on insertion.The patient developed some redness and swelling around the site and when the cannula was removed approx.12 hours later, the retained guidewire was noted and caused a needlestick injury to the nurse removing the device.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
• Type of Device: 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: 11882678
• MDR Text Key: 263522779
• Report Number: 9610847-2021-00232
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833139
• UDI-Public: 00382903833139
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 383313
• Device Lot Number: 0065730
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1