MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 10ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Catalog Number 301029

Device Problems Leak/Splash (1354); Material Protrusion/Extrusion (2979)

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

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Material no.301029, batch no.7339675.It was reported that before use of the bd 10ml syringe luer-lok¿ tip there was a defective molding found during customer incoming inspection.There were three products that were rejected.The following information was provided by the initial reporter: quantity 3.Failure mode."material was rejected through a customer complain due to the following condition: it was reported defective molding during customer inspection.".

Manufacturer Narrative

Investigation: dhr review: release date: (b)(6) 2017.Released quantity was 428,400.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7339675 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Sample evaluation: three photos and two plastic bags containing a total of 114 loose 10ml syringes were received and evaluated.All samples were visually inspected, and the following defects were rejectable per product specification: 6 with plunger rod or barrel damage, 1 with missing print defect, 2 with ink foreign matter, and 6 with burnt plastic embedded foreign matter.The embedded foreign matter samples were from the following: mold c-187 cavity 20, mold c-189 cavity 27, mold c-10 cavity 24, mold c-197 cavity 18,mold c-189 cavity 31, mold c-189 cavity 29.The remaining 99 samples were observed to have cosmetic defects with no effect to the form fit or function of the device and all scale markings containing more than 50% of the intended print and were acceptable per product specification.Root cause: potential root cause for the damaged barrel and plunger rod defect is associated with the assembly process.The plunger rods were most likely damaged due to a broken component directly involved with transferring plunger rods from one dial to another.This could cause the plunger rods to become caught in the dials and becoming damaged.The damaged barrel flange is most likely due to a rail jam.The barrels are fed in a single file, if too many enter the rail at once damaged can occur.Potential root cause for the missing print defect is associated with the assembly process.There is a scuff mark present in the location of the missing print indicating this was most likely caused by the rail jam mentioned above.Potential root cause for the ink foreign matter defect is associated with the marking process.They appear to be contact smears which is most likely caused barrels making contact on the conveyor belt shortly after they were printed.Potential root cause for the embedded foreign defect is associated with the molding process.The embedded fm is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.

Event Description

Material no.301029 batch no.7339675 it was reported that before use of the bd 10ml syringe luer-lok¿ tip there was a defective molding found during customer incoming inspection.There were three products that were rejected.The following information was provided by the initial reporter: quantity 3 failure mode "material was rejected through a customer complain due to the following condition: it was reported defective molding during customer inspection.".

• Brand Name: BD 10ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8720401
• MDR Text Key: 149191513
• Report Number: 1213809-2019-00635
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 301029
• Device Lot Number: 7339675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other