MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 3/10 CC 31 G X 8 MM (5/16 IN); INSULIN SYRINGE AND NEEDLE

Catalog Number 328291

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device expiration date: n/a.(b)(4).

Event Description

It was reported that bd ultra-fine¿ ii short needle insulin syringe 3/10 cc 31 g x 8 mm (5/16 in) had multiple syringes in the lot that came with the scale smudged, difficult plunger, or bent needle.Same product catalog number, and batch.Found before use.No serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: a sample is not available for evaluation.A review of the device history record was completed for batch # 6347543.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted.Conclusion: without a sample an absolute root cause cannot be determined.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 3/10 CC 31 G X 8 MM (5/16 IN)
• 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: 6944934
• MDR Text Key: 90397818
• Report Number: 1920898-2017-00249
• 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: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 328291
• Device Lot Number: 6347543
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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