MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ SYRINGE WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE; SYRINGE WITH HYPODERMIC NEEDLE

Catalog Number 305945

Device Problems Hole In Material (1293); Structural Problem (2506)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 ten "dirty needle stick injuries" occurred to individual nurses while using bd syringe with permanently attached safetyglide needle due to the safety guard "sticking." there was no report of treatment or medical intervention.

Manufacturer Narrative

No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.A dhr check was not performed as the lot number is "unknown" for this complaint.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.

• Brand Name: BD¿ SYRINGE WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE
• Type of Device: SYRINGE WITH HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7444831
• MDR Text Key: 106003924
• Report Number: 1920898-2018-00249
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (y/n): N
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 305945
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other