MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP; PISTON SYRINGE

Catalog Number 326631

Device Problems Defective Device (2588); Packaging Problem (3007)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a complaint history check was performed and this is the 1st related complaint for plunger rod damaged on lot # 0265866.Investigation summary: customer returned (1) 3/10cc,12.7mm, 29g syringe in an open poly bag from lot # 0265866.Customer states that the plunger rod was cracked.The returned syringe was examined and exhibited a broken plunger rod.Manufacturing (holdrege) will be notified of this issue.A review of the device history record was completed for batch # 0265866 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 20apr2021, holdrege received a photo complaint from material #326631 and lot #0265866; syringe 0.3ml 29ga 1/2in.Initial evaluation: examination of the photo indicates damage to the plunger and cap.The plunger tip is present but with obvious damage as it is ¿loosely¿ attached to the plunger rod.Without the plunger tip, it is difficult to operate the syringe.The cap closed end has an opening across half the diameter of the cap.The cap is a sterility barrier.The damage to the cap would affect sterility.It is believed the nonconformance would have had to occur at the form, fill and seal (ffs) operation.The syringe is transported down the ff&s rail guided by the barrel flange manufacturing evaluation: a review of the syringe assembly 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 0265866 was reviewed.The syringes were packaged from 12nov2020 to 13nov2020.During the manufacturing process, the following inspections are completed on regular intervals for the plunger: visual inspection every hour: missing components including plunger rod and cap.Visual inspection every hour: damage defective components including plunger and cap.If a defect is found during an inspection a quality notification is initiated.No quality notifications were written for issues relating to the assembled syringe defect.Reviewed l2l dispatches and logbook entries.#109994 was created for major index jams on 13nov2020.Root cause: a side bolt was out in the guarding causing major index jams.The syringes were catching the guarding and entering the index at an angle creating jams and damage to the syringe.Corrective action: to correct angled syringes from entering the ffss indexer incorrectly, the bolt was replaced in the guard.

Event Description

It was reported that a syringe 0.3ml 29ga 1/2in 7bag 420cas jp was damaged.The following was reported by the initial reporter: "this is a report about a damaged plunger cap and a damaged plunger rod.According to the customer's report, the plunger cap and the plunger rod were both cracked.".

Manufacturer Narrative

The following fields were updated due to additional information: b.5.Describe event or problem: added that product was not sterile h.6.Imdrf annex a grid: added code a0205 h3 other text : see h.10.

Event Description

It was reported that a syringe 0.3ml 29ga 1/2in 7bag 420cas jp was damaged and not sterile.The following was reported by the initial reporter: "this is a report about a damaged plunger cap and a damaged plunger rod.According to the customer's report, the plunger cap and the plunger rod were both cracked.".

• Brand Name: SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11739705
• MDR Text Key: 249521607
• Report Number: 1920898-2021-00482
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 326631
• Device Lot Number: 0265866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1