MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 1 CC 31 G X 8 MM; INSULIN SYRINGE AND NEEDLE

Catalog Number 328289

Device Problems Component Missing (2306); Fail-Safe Problem (2936)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

Results: it is unknown if a sample will be returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6207605.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).

Event Description

It was reported that a consumer suffered a needle stick injury before use from a bd ultra-fine¿ ii short needle insulin syringe, 1 cc 31 g x 8 mm because the needle was missing its shield in a bag.The consumer applied an alcohol wipe to the wound but there was no report of medical intervention.

Manufacturer Narrative

Results: one sample in an open poly bag was returned for evaluation.A visual inspection revealed that the syringe was returned with the shield off in the bag.The syringe was examined and exhibited a bent needle.It was also noted that the cannula was grossly damaged and bent/contorted.Inspection of the interior of the shield noted a single puncture in the inner shield wall, indicative of contact with the cannula.Conclusion: an absolute root cause for this incident cannot be determined.However, our quality engineer notes that a probable root cause is likely that there was an incomplete shielding of the cannula when the syringe was being assembled.Due to the nature of the cannula damage, the shield would not have been able to properly seat on the syringe barrel, thus making it more likely that it could dislodge in transit or with additional handling.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 1 CC 31 G X 8 MM
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6570548
• MDR Text Key: 75443859
• Report Number: 1920898-2017-00061
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328289
• Device Lot Number: 6207605
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• 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): Other