MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD RELION INSULIN SYRINGE 1/2 ML, 31 G X 8 MM

Catalog Number 328509

Device Problem Insufficient Information (3190)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.This device does not have an expiration date.It is unknown if a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the customer reached into her son's box of syringes and one of the needles was protruding through the polybag.Her finger was stuck by the needle, drawing blood.The customer went to the doctor who cleaned the wound and administered a tetanus shot.The doctor told the customer no further medical attention was needed.

Manufacturer Narrative

Results - the customer returned (1) 1/2cc, 8mm, 31g relion syringe in an open poly bag from lot number 5208886.The syringe was returned with the shield off of the syringe in the poly bag.The syringe was examined and exhibited a bent cannula.The shield was examined and no holes caused by the cannula were observed in the shield.Since the shield was off in the bag, exposing the cannula, a needle stick could occur.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5208886.The device was manufactured between 10/1/2015 and 10/3/2015.Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure of needle stick and shield off in the bag.After initial investigation, the sample was sent to the manufacturing site for additional evaluation.It was reported that a misaligned laser sensor (raised shield/gate flash) from its designated detecting position may result in sending defective parts with gate flash and/or raised shields to packaging and to market as ¿good¿ product.Bd will continue to monitor trends and investigate special causes.An absolute root cause was not identified.

• Brand Name: BD RELION INSULIN SYRINGE 1/2 ML, 31 G X 8 MM
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5606243
• MDR Text Key: 43585157
• Report Number: 1920898-2016-00014
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

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: Lay User/Patient
• Device Catalogue Number: 328509
• Device Lot Number: 5208886
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention