MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 3/10 ML, 31 G X 6 MM BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

Catalog Number 324909

Device Problems Bent (1059); Device Markings/Labelling Problem (2911); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: n/a investigation: a sample is not available for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot numbers.Without a sample, an absolute root cause for this incident cannot be determined.(b)(4).

Event Description

It was reported that a consumer of the bd insulin syringe with bd ultra-fine¿ needle received a package that contained mismarked scale print on syringe, difficult plunger rod movement and bent needles.This was noticed before use and there was no report of injury or medical interventions.

• Brand Name: 3/10 ML, 31 G X 6 MM BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• 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: 6919643
• MDR Text Key: 89876481
• Report Number: 1920898-2017-00232
• 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
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324909
• Device Lot Number: 7023686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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