MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS

Catalog Number 300841

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the syringe 1ml ls 25ga 5/8in chin graphics experienced breakage during use.The following information was provided by the initial reporter: when removing the syringe after injection, nurse found the needle separation from needle hub and leaved in the patient's body.The broken needle have been removed by hand.

Manufacturer Narrative

Investigation: dhr's were performed and there were no quality notifications raised in the past 12 months and no abnormalities found.Photo evaluation one photo was received and evaluated.The photo observed the needle detach from hub.Sample evaluation one actual sample with open package returned for investigation from the returned sample, we had observed the needle hub with cover and cannula detach from the hub.Further analysis observed that there is no epoxy on the needle hub and epoxy on the cannula.From the returned sample, observed the cannula with the epoxy and detach from the needle hub and no epoxy on the hub.Investigation was carried out on needle assembly process.At needle assembly line, there is dosing at the epoxy station.Suspected the dosing of the epoxy to be out of position from the area where cannula joins the hub.This cause the cannula not to bond to the hub.This could happen when the cannula station restarts after there are machine stoppages.The production technician is to remove the first rack once the machine start running again to prevent parts with improper epoxy dosing from flowing to the next station.The production technician may fail to remove the first rack, this result in the nonconformance part flowing to the next process.Probable root cause could be due to the dosing of epoxy out of position from the cannula joins at hub and production technician fail to remove from the first rack.On-job training (ojt-41381) was updated for needle assembly line troubleshooting for excessive epoxy to remove the first rack whenever there is restart after cannulation station stoppage by 30-oct-2018.The affected batch was produced before the corrective action.

Event Description

It was reported that the syringe 1ml ls 25ga 5/8in chin graphics experienced breakage during use.The following information was provided by the initial reporter: when removing the syringe after injection, nurse found the needle separation from needle hub and leaved in the patient's body.The broken needle have been removed by hand.

• Brand Name: SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8561803
• MDR Text Key: 143452589
• Report Number: 8041187-2019-00331
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 300841
• Device Lot Number: 8264079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other