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

Model Number 305950

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe alrg sftygld 1ml w/ndl 27x1/2 rb plunger rod was broken and difficult to move.The following information was provided by the initial reporter: material no: 305950, batch no: 0104234.It was reported i can not pull the plunger back, missing cap and loose.The end of plunger broken.Verbatim: when i pull the plunger back, i can not pull the plunger back.It is as if the black part is too large for the syringe.Also, a few did not have a cap on them or they are so loose they fall off.The end of the plunger is broken off too.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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 [200889459, 200886401, 200889320] noted that did not pertain to the complaint.H3 other text : see h.10.

Event Description

It was reported that syringe alrg sftygld 1ml w/ndl 27x1/2 rb plunger rod was broken and difficult to move.The following information was provided by the initial reporter: material no: 305950 batch no: 0104234.It was reported i can not pull the plunger back, missing cap and loose.The end of plunger broken.Verbatim: when i pull the plunger back, i can not pull the plunger back.It is as if the black part is too large for the syringe.Also, a few did not have a cap on them or they are so loose they fall off.The end of the plunger is broken off too.

• Brand Name: SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11181760
• MDR Text Key: 227930147
• Report Number: 1920898-2021-00078
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1