MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1ML 29G 12.7MM 10BAG 500 EU

Catalog Number 324827

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that syringe 1ml 29g 12.7mm 10bag 500 eu leaked.The following information was provided by the initial reporter: the patient contacted regarding insulin syringes.He injects painkillers with syringes.When he inject, some of the liquid will drain past the syringe.In addition, the injection sometimes makes you sore and the injection site also becomes bloody.

• Brand Name: SYRINGE 1ML 29G 12.7MM 10BAG 500 EU
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12601278
• MDR Text Key: 280766538
• Report Number: 1920898-2021-01058
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324827
• Device Lot Number: 9182213
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1