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

Catalog Number 328325

Device Problems Bent (1059); Material Perforation (2205); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 that before use, a bd ultra-fine insulin syringe and needle was found with the needle bent and through the orange protection cap.The package was perforated injuring an employee.There was no report found of medical intervention needed or performed regarding the "employee injury.".

Manufacturer Narrative

Investigation results: severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint for cannula through shield and needle stick on lot # 7044954.As per manufacturing, a review of the device history record was completed for batch# 7044954.All inspections and challenges were performed per the applicable operations qc specifications.There were four (4) notifications [(b)(4)] noted that did not pertain to the complaint.Two investigations were completed.One in the (b)(4) facility and one in (b)(4) facility.(b)(4) investigation summary: customer returned (10) 1/2cc, 8mm, 30g syringes in a sealed poly bag from lot # 7044954.Customer states that the needle was through the orange protection cap, perforated the package, and injured an employee.The returned poly bag was examined and exhibited one syringe with the cannula through the shield.Since one sample exhibited the cannula through the shield, exposing the cannula, a needle stick could occur.(b)(4) investigation summary: on 30jan2018, (b)(4) received ten (10) 0.5ml, 8mm, 30g syringes in unopened polybag from batch # 7044954.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, similar findings were noted as found during initial investigation at (b)(4).Probable root cause is likely due to the cannula being bent during the shielding process on the needle lines.While the lines have a point inspect machine (pim) that passes an electrical current over the shield to detect any arcs, this type of inspection is not fail proof.Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure (needle stick and cannula through shield).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Possible root causes for needle through shield include: 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.Based on the above, no capa is required at this time.

• Brand Name: BD ULTRA-FINE INSULIN SYRINGE AND NEEDLE
• Type of Device: HYPODERMIC SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7113215
• MDR Text Key: 95072603
• Report Number: 1920898-2017-00369
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• 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: 328325
• Device Lot Number: 7044954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Date Manufacturer Received: 11/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other