MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31GX5/16"; INSULIN SYRINGE AND NEEDLE

Catalog Number 328418

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.Medical device expiration date: this device does not have an expiation date.(b)(4).Device manufacture date: 02sep2016 to 04sep2016.Result - a sample was not returned for evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6193975.Conclusions - as there was no actual sample returned for evaluation, an absolute root cause for this incident cannot be determined.If a sample is returned after this time, an investigation will be performed and a supplemental report will be filed.

Event Description

It was reported that the needle of the suspect device was left uncovered and the needle shield was not in the bag.When the consumer reached into the bag he was stuck by the needle.

Manufacturer Narrative

Results: one used sample in an open poly bag was returned for evaluation.A visual inspection revealed that the syringe was without its safety shield and exhibited a bent cannula.As previously reported, a review of the device history record revealed no irregularities during the manufacture of the reported lot # (b)(4).Conclusion: a root cause for this incident has not yet been determined.The sample has been forwarded to the manufacturing site in holdrege, ne for further evaluation.Upon completion of the secondary investigation, a second supplemental report will be filed.

Manufacturer Narrative

Results: a secondary investigation was completed by the manufacturing site in (b)(6).One used samples was visually inspected and revealed similar findings to that of the primary investigation - the syringe was without its safety shield and exhibited a bent cannula.As previously reported, a review of the device history record revealed no irregularities during the manufacture of the reported lot # 6193975.Conclusion: an absolute root cause for this incident cannot be determined.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31GX5/16"
• 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: 6390352
• MDR Text Key: 69755882
• Report Number: 1920898-2017-00033
• 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,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328418
• Device Lot Number: 6193975
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other