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

Catalog Number 326719

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).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 with the use of the bd ultra-fine¿ insulin syringe there was an issue with sterile breach.There was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: customer returned (1) 1cc, 12.7mm, 29g syringe in a sealed blister pack from lot # 7023616.Customer states that the needle is protruding through the packaging.The returned syringe was examined and exhibited the needle through the shield.(b)(4) was initiated by the holdrege plant to address needle through shield for 1ml syringes produced on the syringe floor, and their associated root cause(s).Batch# 7023616 was manufactured prior to initiation of this capa.A review of the device history record was completed for batch# 7023616.All inspections were performed per the applicable operations qc specifications.There were (2) notifications [200681525, 200681562] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure investigation conclusion: possible root causes for needle through shield include - manufacturing process: needle was bent during the shielding process and was not detected at the point inspect machine, where an electrical current is passed over the shield and ejects parts where an arc is detected.Additionally, needle through shield would have had to pass through undetected by the camera system utilized on the production line.Both systems are challenged at regular intervals during production.(b)(4) was initiated by the holdrege plant to address needle through shield for 1ml syringes produced on the syringe floor, and their associated root cause(s).Batch# 7023616 was manufactured prior to initiation of this capa.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture.

Event Description

It was reported with the use of the bd ultra-fine¿ insulin syringe there was an issue with sterile breach.There was no report of injury or further medical intervention.

• Brand Name: BD ULTRA-FINE¿ 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: 7745304
• MDR Text Key: 116050332
• Report Number: 1920898-2018-00559
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K955235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 326719
• Device Lot Number: 7023616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other