MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML ALLERGIST TRAY WITH 26 G X 3/8 IN SAFETYGLIDE; PISTON SYRINGE

Catalog Number	305951
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that a 1 ml allergist tray with 26 g x 3/8 in safetyglide had a safety mechanism that would not advance onto the needle after use.This occurred on 4 separate occasions but the date/time and or patient information is unknown.
Additional Manufacturer Narrative
Investigation summary: customer returned (5) 1ml, 10mm, 26g bd safetyglide allergy syringes in an open tray.Customer states that the safety mechanism would not advance onto the needle after it had been used.All returned syringes were tested and all safety mechanism were able to be properly activated with no observed defects.A dhr check was not performed as the lot number is "unknown" for this complaint.Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that a 1 ml allergist tray with 26 g x 3/8 in safetyglide had a safety mechanism that would not advance onto the needle after use.This occurred on 4 separate occasions but the date/time and or patient information is unknown.

• Brand Name: 1 ML ALLERGIST TRAY WITH 26 G X 3/8 IN SAFETYGLIDE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8367249
• Report Number: 1920898-2019-00204
• Device Sequence Number: 183566
• Product Code: MEG
• UDI-Device Identifier: 30382903059516
• UDI-Public: 30382903059516
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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
• Operator of Device: Other
• Device Catalogue Number: 305951
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other