MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE; INSULIN SYRINGE WITH NEEDLE

Catalog Number 328278

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that bd ultra-fine¿ needle insulin syringe broke in a male consumer during use.The consumer visited the emergency room for removal of the syringe.However, the syringe could not be located via x-ray.There was no additional information regarding treatment or medical intervention.

Manufacturer Narrative

Investigation summary: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Device history record review ¿ a review of the device history record was completed for batch# 6291506.All inspections were performed per the applicable operations qc specifications.Syringe assembly ¿ there was one (1) batch of material# 700007435 (syringe 1.0ml asm 30ga 1/2in tw sm700177) that went into finished batch# 6291506; batch# 6291506.Date(s) of manufacture: 16dec2016 thru 19dec2016.Machine(s) manufactured on: jn, jm, jo, jl.Pils ¿ there was one (1) batch of material# 700007432 (barrel 1.0ml shd 30ga 1/2in tw sm700177) that went into finished batch# 6291506; batch# 6291506.Date(s) of manufacture: 16dec2016 to 19dec2016.Machine(s) manufactured on: fk.There were zero (0) notifications noted that pertained to this complaint.Severity: s_3_; occurrence: a complaint history check was performed and this is the 1st related complaint for needle broke off during use and the 1st related complaint for needle bent before use on lot # 6291506.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7460222
• MDR Text Key: 106518799
• Report Number: 1920898-2018-00264
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282784
• UDI-Public: 00382903282784
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328278
• Device Lot Number: 6291506
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention