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

Catalog Number 326638

Device Problem Delivered as Unsterile Product (1421)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Needle Stick/Puncture (2462)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the syringe 0.3 ml 30ga 8 mm 7bag 420cas jp needle pierced through the shield before use, breaking the sterile barrier and resulting in a clean needle stick.The following information was provided by the initial reporter, translated from (b)(6) to english: "the needle pieirced the shield and needle stick injury occurred.The finger was bleeding and customer had pain.".

Manufacturer Narrative

Investigation summary: customer returned (1) loose 3/10cc syringe.Customer states that the needle pierced the shield and needle stick injury occurred and the finger was bleeding and customer had pain.The returned syringe was examined and exhibited the cannula through the shield, exposing the cannula, which could cause a needle stick, bleeding, and pain.Unable to perform dhr check for cannula through shield, needle stick injury (before use), harm/bleeding and needle pain due to unknown lot number.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 18th sep 2019, holdrege received photo of a insulin syringe of an unknown batch# : after visual inspection of the sample, we would confirm that it is cannula through shield and happened after getting cannulated, passed the pim inspection for cannula angularity.It must have happened during the process of shielding.Process: ¿ racks loaded with hubs travel down a conveyor towards the cannulator.¿ they approach the cannulator turning horizontally in order to receive cannula.¿ racks pass under mars magnet straightening the cannula in the hubs.The rack passes under two ultraviolet lamps, which causes the adhesive to cure.¿ then the racks go to the shielder with the use of linear motion.The rack locator positions the racks while getting shielded.¿ the parts are first inspected with an angularity camera, and if the angle of the cannula is too great or there is nothing on that pin, the part is not shielded.¿ the finished product pick and place head won¿t pick it up in the gripper as it is gripping the shield for pick up.Investigation: batch number is not available.Not able to review l2l dispatches for repairs/ adjustments.Root cause: root cause cannot be determined as the batch number is not available.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.".

Event Description

It was reported that the syringe 0.3ml 30ga 8mm 7bag 420cas jp needle pierced through the shield before use, breaking the sterile barrier and resulting in a clean needle stick.The following information was provided by the initial reporter, translated from japanese to english: "the needle pierced the shield and needle stick injury occurred.The finger was bleeding and customer had pain.".

• Brand Name: SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8981198
• MDR Text Key: 158135590
• Report Number: 1920898-2019-00949
• 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
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326638
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other