MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; SYRINGE, ANTISTICK

Catalog Number 305934

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Initial reporter phone #: an additional phone # was provided as (b)(6).Device manufacture date: unknown.Investigation summary: since no samples (including photos) were returned for the reported issue of ¿needle stick injury¿, with reported lot # unknown regarding item # 305934, the complaint could not be confirmed, and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.Unable to complete dhr check as the lot number is unknown.Bd was not able to duplicate or confirm the indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the investigation, no additional investigation and no capa is required at this time.Investigation conclusion: unable to complete complaint lot history check as the lot number is unknown unable to complete dhr check as the lot number is unknown as no samples and/or photo(s) were 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 root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no capa/sa is required at this time.

Event Description

It was reported that the 1/2 ml bd safetyglide¿ insulin syringe with attached needle was involved with an adverse event without an identified device or use problem.It has not been specified whether medical intervention was applied as a result of the needle stick injury.The following information was provided by the initial reporter: material no.: 305934, batch no.: unknown.Increased number of nurse needle sticks that seem to have been with the safety glide syringes.Nurses goto push to engage the safety and their thumbs slip past the safety causing a needle stick.

• Brand Name: 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11467086
• MDR Text Key: 239720692
• Report Number: 1920898-2021-00287
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 305934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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