MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

Catalog Number 326638

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

It was reported that syringe 0.3ml 30ga 8mm 7bag 420cas jp stopper was damaged, had foreign matter, and the plunger rod was broken.The following information was provided by the initial reporter: the customer (animal clinic) reported the following three issues of syringe: (1) damaged stopper: the stopper was deformed.(2) fm (dirt): the inside of the barrel was dirty.(3) broken plunger rod: the plunger rod was broken.

Manufacturer Narrative

Investigation summary: customer returned (3) 3/10cc, 8mm, 30g syringes in an open poly bag from lot # 0248506.Customer states that the stopper was deformed, the plunger rod was broken, and the inside of the barrel was dirty.All returned syringes were examined and one sample exhibited the stopper separated from the plunger rod.Manufacturing ((b)(4) ) will be notified of this issue.A review of the device history record was completed for batch # 0248506 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.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 (stopper separates) complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Initial evaluation: visual inspection of the photo displays 2 syringes; one with a missing plunger tip and one that the plunger is not attached to the stopper.There is no presence of a cap, and there is no other obvious damage or fm noted on the syringe.Manufacturing evaluation: a review of the packaging line where the syringe in question was produced was completed.Process summary: a dial transfers the correct number of syringes to a tube where they drop by gravity through the tube coming to rest on top of the polybag sealing jaws.The polybag is formed by web that is wrapped around a metal tube where the sides of the web overlap and are sealed to form the vertical seal.Sealing jaws form the polybag bottom, as well as the top of the previous polybag.Between the sealing jaws is a knife that severs the bag from the roll.Device history record; l2l and logbook evaluation: the device history (dhr) for batch 0248506 was reviewed and zero quality notifications were written for issues relating to the assembled syringe defect.The syringes were assembled from 08oct2020 to 09oct2020.During the manufacturing process, the following inspections are completed on regular intervals: 1.Correct quantity every hour: quantity shall match packaging specification requirements.2.Syringe quality every hour: missing and/or unassembled components.3.Syringe quality after packaging every hour: damaged bags and/or syringes if a defect is found during an inspection a quality notification is initiate notifications and maintenance dispatch (l2l) was reviewed, and no dispatches or notifications were created from 30apr2020 thru 01may2020 that would cause the needle assembly unit to become unattached.Root cause: root cause for this defect cannot be determined.

• Brand Name: SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12600123
• MDR Text Key: 281091184
• Report Number: 1920898-2021-01056
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326638
• Device Lot Number: 0248506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1