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

Catalog Number 305945

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

Medical device lot #: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported with the use of the bd¿ syringe with permanently attached safetyglide¿ needle there was an issue with a needle stick injury.It was stated ¿the employee was stuck after injecting heparin while engaging safety device.Safety device was difficult to engage.The device "catches" and does not engage smoothly.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use?: no device returned to manufacturer: no.This supplemental mdr also corrects the following fields: it was reported with the use of the bd¿ syringe with permanently attached safetyglide¿ needle there was an issue with a needle stick injury.It was stated ¿the employee was stuck after injecting heparin while engaging the safety device.The safety device was difficult to engage.The device "catches" and does not engage smoothly.¿ medical intervention is unknown.Type of reportable events: serious injury.

Event Description

It was reported with the use of the bd¿ syringe with permanently attached safetyglide¿ needle there was an issue with a needle stick injury.It was stated ¿the employee was stuck after injecting heparin while engaging the safety device.The safety device was difficult to engage.The device "catches" and does not engage smoothly.¿ medical intervention is unknown.

Manufacturer Narrative

Investigation summary: 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.Unable to complete dhr check as the lot number is unknown.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.Based on the above, no additional investigation and no capa is required at this time.Investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

Event Description

It was reported with the use of the bd¿ syringe with permanently attached safetyglide¿ needle there was an issue with a needle stick injury.It was stated ¿the employee was stuck after injecting heparin while engaging safety device.Safety device was difficult to engage.The device "catches" and does not engage smoothly.There was no report of injury or further medical intervention.

• Brand Name: BD¿ SYRINGE WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE
• Type of Device: SAFETY ENGINEERED SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7515498
• MDR Text Key: 108300854
• Report Number: 1920898-2018-00318
• 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: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2018

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: Other
• Device Catalogue Number: 305945
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 04/25/2018; 04/25/2018
• Supplement Dates FDA Received: 07/17/2018; 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other