MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB; PISTON SYRINGE

Model Number 305950

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 4 cases of syringes alrg sftygld 1ml w/ndl 27x1/2 rb had difficult plunger movement.The following information was provided by the initial reporter: "the customer reported that four cases of bd pn 1cc 27g x ½ safety syringe (item# bd5950 lot# 0104234) had plungers that were difficult to move.".

Manufacturer Narrative

H.6.Investigation: the samples were received by bd for evaluation.A quality engineer was able to review the returned (3425) 1ml, 13mm, 27g bd safetyglide allergy syringes in 135 sealed trays from lot # 0104234 product # 305950 with the reported issue of ¿plungers were difficult to move¿.30 out of 3425 samples were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 0104234.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.

Event Description

It was reported that 4 cases of syringes alrg sftygld 1ml w/ndl 27x1/2 rb had difficult plunger movement.The following information was provided by the initial reporter: "the customer reported that four cases of bd pn 1cc 27g x ½ safety syringe (item# bd5950 lot# 0104234) had plungers that were difficult to move.".

• Brand Name: SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11103419
• MDR Text Key: 229408195
• Report Number: 1920898-2020-01784
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903059509
• UDI-Public: 30382903059509
• Combination Product (y/n): N
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305950
• Device Catalogue Number: 305950
• Device Lot Number: 0104234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1