MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 31 G X 6MM BD ULTRA-FINE¿ INSULIN SYRINGE

Catalog Number 324903

Device Problems Use of Device Problem (1670); Device Damaged Prior to Use (2284); Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Results: a sample is not available for evaluation, however, the customer provided photos for investigation.The photos have not yet been evaluated but the manufacturing site has provided a device history record review.There were two defects noted during production of this batch.In both instances (200595625 and 200595615), the errors noted were for unrelated issues from the complaint listed above.Conclusion: a conclusion is not yet available.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a needle stick injury occurred with a 31 g x 6mm bd ultra-fine¿ insulin syringe due to the device's cap falling off.The injury was prior to patient use while the user was arranging insulin syringes into an acrylic box.The user stated she is still breast feeding and reported the incident to a doctor.The user received (b)(6) antibody, (b)(6) surface antigen, and (b)(6) testing.

Manufacturer Narrative

Investigation: customer returned photos of a poly bag of 1cc, 6mm, 31g syringes in a poly bag from lot # 5138870.Customer states that they were pricked by the syringe with the cap off.The attached photos were examined and no syringe in the photos exhibited the shield off of the syringe that could cause a needle stick.As per manufacturing, there were two (2) defects noted during production of this batch.In both instances (200595625 & 200595615), the errors noted were for unrelated issues from the complaint.Conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (shield missing and needle stick).

• Brand Name: 31 G X 6MM BD ULTRA-FINE¿ INSULIN SYRINGE
• 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: 6620441
• MDR Text Key: 76943385
• Report Number: 1920898-2017-00071
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 324903
• Device Lot Number: 5138870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention