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

Catalog Number 305945

Device Problems Failure to Deliver (2338); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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.A dhr check was not performed as the lot number is "unknown" for this complaint.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd¿ syringe with permanently attached bd safetyglide¿ safety needle safety mechanism was "warped" and would not close during use, nor could the serum be drawn up when pulling back on the plunger.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "as far as sample i have not ran into warped syringes as of lately, warped as in the safety does not close, or the serum cannot be drawn up as when pulling the plunger to drawn meds.".

• Brand Name: BD SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE SAFETY NEEDLE
• Type of Device: PISTON SYRINGE
• 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 ; 8015652341
• MDR Report Key: 9355036
• MDR Text Key: 195467191
• Report Number: 1920898-2019-01305
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/08/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/21/2019
• 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