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

Catalog Number 300841

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem Pain (1994)

Event Date 08/05/2019

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 difficult plunger movement prior to use.The following information was provided by the initial reporter: at 9:00 on (b)(6) 2019, patient performed dynamic imaging of salivary glands in the clinic.Before the imaging, intravenous radiopharmaceutical drugs were needed.With a 1 ml syringe, the patient complained of pain at the needle eye during the injection, and the nurse felt that the plunger moved difficult.There is a sense of insensitivity.When the needle is pulled, the patient feels more painful.The needle is replaced and re-injected.The process is smooth.Checking the needle tip and finding a small bump under the needle tip is the main cause of blunt and painful injection.

Manufacturer Narrative

Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

Event Description

It was reported that the syringe 1ml ls 25ga 5/8in chin graphics experienced difficult plunger movement prior to use.The following information was provided by the initial reporter: at 9:00 on (b)(6) 2019, patient performed dynamic imaging of salivary glands in the clinic.Before the imaging, intravenous radiopharmaceutical drugs were needed.With a 1 ml syringe, the patient complained of pain at the needle eye during the injection, and the nurse felt that the plunger moved difficult.There is a sense of insensitivity.When the needle is pulled, the patient feels more painful.The needle is replaced and re-injected.The process is smooth.Checking the needle tip and finding a small bump under the needle tip is the main cause of blunt and painful injection.

• 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: 9186826
• MDR Text Key: 168684364
• Report Number: 8041187-2019-00817
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 300841
• Device Lot Number: 8172263
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other