MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE쳌¿ II 0.3ML, 8 MM INSULIN SYRINGE; INSULIN SYRINGE AND NEEDLE

Catalog Number 328322

Device Problems Fail-Safe Design Failure (1222); Malposition of Device (2616)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Device evaluation: photos and 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 picked up the package of the suspect device and received a needle stick injury.He looked at the package and noted a syringe with the needle through the shield.The customer did not receive any medical intervention.

Manufacturer Narrative

Device evaluation: result - the customer returned (10) 3/10cc, 8mm, 30g syringes in an open poly bag.All returned syringes were examined and one sample exhibited the needle through the shield.This is also noted in the returned photos.Since the needle was through the shield, exposing the cannula, a needle stick could occur.A review of the device history record was completed for the reported lot #5338961.All challenges and inspections were performed per the applicable operations qc specifications.Conclusion - bd was able to confirm the customer¿s indicated failure of needle stick and needle through the shield.A probable root cause for this incident is misalignment of the rollover bar to the needle assembly rack at the shielding operation.Occasionally, a rack jam will occur in the tracks at the shielder and cause the machine to go out of time, misaligning the racks.When this happens the racks do not line up with the holes in the rollover bar.When the rollover bar rolls over to put the shield on the hub the cannula may go through the wall of the shield causing a needle through shield defect.Current controls and corrections are in place.Bd will continue to monitor for trends and special causes.

• Brand Name: BD ULTRA-FINE쳌¿ II 0.3ML, 8 MM INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• 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: 6187251
• MDR Text Key: 63136224
• Report Number: 1920898-2016-00061
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K955235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 328322
• Device Lot Number: 5338961
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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