MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE; SAFETY SYINGE WITH NEEDLE

Catalog Number 328446

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7332703.Medical device expiration date: 2022-11-30.Device manufacture date: 2017-11-28.Medical device lot #: 7332705.Medical device expiration date: 2022-11-30.Device manufacture date: 2017-11-28.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 after activation of the bd safetyglide¿ insulin syringe safety feature, the entire needle fixture separated from the syringe.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: customer returned one bd 1ml, 6mm, 31g safetyglide insulin syringe in an open blister pack from lot # 7332705 and one bd 1ml, 6mm, 31g safetyglide insulin syringe in an open blister pack from lot # 7332703 along with one open, empty blister from lot # 7296708.Both returned syringes were returned with the hub-needle-safety mechanism assembly separated from the barrel.No damage to the barrels was observed.All samples were visualized under 4x magnification with no damage or defects noted during this evaluation.A dhr review was performed by the holdrege plant with no related quality notifications for any of these batches were noted.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.Probable root cause unable to be determined at this time as there is no evidence to suggest a failure mode, as noted through evaluation of the supplied samples.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE
• Type of Device: SAFETY SYINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7375234
• MDR Text Key: 103723456
• Report Number: 1920898-2018-00203
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 328446
• Device Lot Number: SEE H.10.
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other