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

Catalog Number 305945

Device Problems Mechanical Problem (1384); Sticking (1597)

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 lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Without a sample, an absolute root cause for this incident cannot be determined.(b)(6).

Event Description

It was reported with the use of the bd¿ syringe with permanently attached safetyglide¿ needle there was an issue with needle sticks to nurses.It was stated ¿ten dirty needle stick injuries have occurred.Unknown batch/lots.Because of the functional use of the slider (white cap); that's what's causing the needle sticks.It's very sticky, not like other products with safety guards.It's just the product.Not the same nurse in any of these instances.¿ there was no report of further medical intervention.

• Brand Name: BD¿ SYRINGE WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7475836
• MDR Text Key: 106995796
• Report Number: 1920898-2018-00309
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• 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: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2018
• 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