MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS; PISTON SYRINGE

Catalog Number 328431

Device Problems Defective Device (2588); Material Protrusion/Extrusion (2979)

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

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one syringe 0.3 ml 30 ga 1/2 in uf 10bag 500cs has been found damaged and with molding defects during use.The following has been provided by the initial reporter: it was reported that the needle shield looked like chewed up as machine did something during manufacturing.And it is very tight to remove.Verbatim: from phone call: pet owner reported the needle shield looked like chewed up as machine did something during manufacturing.And it is very tight to remove.He did not want to get hurt he has not used that.Sample available.It came from a sealed bag.Item# 328431; lot# 9007855; expiration date-01-31-2019.Incident date (b)(6) 2019; occurence-1.Explained consumer there is no human intervention and syringes are manufactured in a machine.He uses the new needle each time for his pet.

Manufacturer Narrative

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 review of the device history record was completed for batch # 9007855 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted that did not pertain to the complaint.There was one (1) notification [(b)(4)] noted for damaged shields.As no samples and/or photo(s) were received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failures as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It has been reported that one syringe 0.3ml 30ga 1/2in uf 10bag 500cs has been found damaged and with molding defects during use.The following has been provided by the initial reporter: it was reported that the needle shield looked like chewed up as machine did something during manufacturing.And it is very tight to remove.Verbatim: from phone call: pet owner reported the needle shield looked like chewed up as machine did something during manufacturing.And it is very tight to remove.He did not want to get hurt he has not used that.Sample available.It came from a sealed bag.Item# 328431; lot# 9007855; expiration date-01-31-2019.Incident date-(b)(6) 2019 occurence-1.Explained consumer there is no human intervention and syringes are manufactured in a machine.He uses the new needle each time for his pet.

Event Description

It has been reported that one syringe 0.3ml 30ga 1/2in uf 10bag 500cs has been found damaged and with molding defects during use.The following has been provided by the initial reporter: it was reported that the needle shield looked like chewed up as machine did something during manufacturing.And it is very tight to remove.Verbatim: from phone call: pet owner reported the needle shield looked like chewed up as machine did something during manufacturing.And it is very tight to remove.He did not want to get hurt he has not used that.Sample available.It came from a sealed bag.Item# 328431; lot# 9007855; expiration date-01-31-2019.Incident date-08-08-2019; occurence-1.Explained consumer there is no human intervention and syringes are manufactured in a machine.He uses the new needle each time for his pet.

Manufacturer Narrative

H.6.Investigation summary: customer returned (1) loose 3/10cc syringe.Customer states that the needle shield looked like chewed up as machine did something during manufacturing and it is very tight to remove.The returned syringe was examined and exhibited a damaged shield which was very difficult to remove from the hub by hand.A review of the device history record was completed for batch # 9007855 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200799270] noted that did not pertain to the complaint.There was one (1) notification [200799148] noted for damaged shields.Based on the samples and/or photo(s) received the investigation concluded: -confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.As per investigation completed by manufacturing, "on 19 aug 2019, holdrege received a photo complaint for damaged shield.Visual inspection of the photo exhibited a damaged shield.The shield was damaged in 2 different places.Process summary: automatic syringe assembly machine, which feeds 3/10cc, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Root cause: the air jet at the dead block/infeed into the dial was out of adjustment.Zm notification 200799148 was created on (b)(6) 2018 for damaged shields.Corrective action: adjusted air jet at dead block/infeed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.".

• Brand Name: SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8931325
• MDR Text Key: 155650468
• Report Number: 1920898-2019-00871
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 328431
• Device Lot Number: 9007855
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/09/2019; 08/09/2019
• Supplement Dates FDA Received: 09/13/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other