MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 28GA 1/2IN 10BAG 500 BDD; PISTON SYRINGE

Catalog Number	329410
Medical Device Problem Codes	Leak/Splash (1354); Delivered as Unsterile Product (1421); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that syringe 1.0ml 28ga 1/2in 10bag 500 bdd was damaged.This was discovered during use.The following information was provided by the initial reporter: material no: 329410, batch no: 7100965 it was reported plunger rod bent, separated from rubber stopper, plunger cap loose inside of bag.
Additional Manufacturer Narrative
Investigation: customer returned (2) 1cc, 12.7mm, 28g syringe in open poly bags from lot # 7100965.Customer states that the plunger rod is bent, separated from the rubber stopper, and the plunger cap is loose inside the bag.Both returned syringes were returned with the plunger cap off of the syringe in the poly bag.Also, one sample exhibited a deformed thumb press caused by the crushed plunger cap.No stopper was observed to be separated from the plunger rod.A review of the device history record was completed for batch# 7100965.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted for breakout/ sustaining.- confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (plunger cap off in the bag, crushed plunger cap) - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (stopper separates) the syringe was packaged into a polybag.The polybag is pulled through the packaging machine by the movement of the jaw arms.The functions in the cross sealing system are upper and lower cross sealing, perforation of the polybag, and the cutting of the polybag.The cross seal on the polybag is formed by use of an air cylinder driven jaw set.The sealing jaw forms the polybag bottom, as well as the top of the previous bag.Syringes are fed into the polybag via gravity.Between the sealing jaws resides a cutoff knife that severs the polybag from the roll.Unable to determine the root cause of the syringe being caught in the sealing jaw.
Event or Problem Description
It was reported that syringe 1.0ml 28ga 1/2in 10bag 500 bdd was damaged.This was discovered during use.The following information was provided by the initial reporter: material no: 329410 batch no: 7100965.It was reported plunger rod bent, separated from rubber stopper, plunger cap loose inside of bag.

• Brand Name: SYRINGE 1.0ML 28GA 1/2IN 10BAG 500 BDD
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9153099
• Report Number: 1920898-2019-01085
• Device Sequence Number: 14009110
• Product Code: FMF
• UDI-Device Identifier: 30382903294108
• UDI-Public: 30382903294108
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 329410
• Device Lot Number: 7100965
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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