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)

Catalog Number 328291

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a two used samples were returned for evaluation.A visual inspection revealed the units were without the plunger cap or any packaging.Both returned syringes were tested to determine the shield removal forces and the removal forces fell within specification.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6207712.Conclusion: 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 consume stuck herself with a bd ultra-fine¿ ii short needle insulin syringe 3/10 cc 31 g x 8 mm (5/16 in) before use because she had difficulty removing the cap.There was no report of medical intervention.

• 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
• 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: 6538983
• MDR Text Key: 74412621
• Report Number: 1920898-2017-00057
• 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: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328291
• Device Lot Number: 6207712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other