MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX

Catalog Number 324892

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inflammation (1932)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 5047782.Medical device expiration date: 04/30/2020.Device manufacture date: 02/16/2015.Medical device lot #: 5348743, medical device expiration date: 02/28/2021.Device manufacture date: 12/14/2015.Medical device lot #: 6172646, medical device expiration date: 08/31/2021, device manufacture date: 06/20/2016.

Event Description

It has been reported that the syringe 0.5ml 29ga 12.7mm blister 200bx has been found experiencing patient-device incompatibility during use.The following has been provided by the initial reporter: inflammatory reaction after administration of a drug with one of the lots mentioned.

Manufacturer Narrative

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# 5348743.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch# 6172646.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted that did not pertain to the complaint.A review of the device history record was completed for batch# 5047782.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted that did not pertain to the complaint.

Event Description

It has been reported that the syringe 0.5ml 29ga 12.7mm blister 200bx has been found experiencing patient-device incompatibility during use.The following has been provided by the initial reporter: inflammatory reaction after administration of a drug with one of the lots mentioned.

• Brand Name: SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8944364
• MDR Text Key: 155956045
• Report Number: 1920898-2019-00882
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324892
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other