MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL BNS; PISTON SYRINGE

Catalog Number 309648

Device Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)

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

Event Date 07/20/2021

Event Type  malfunction  

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 Description

It was reported that syringe 1ml ll bns had scale marking issues on 13 occasions, foreign matter on 7 occasions, and was damaged on 2 occasions.The following information was provided by the initial reporter: deviations: brown, burned material ¿ 7 syringes, missing stopper ¿ 1 syringe, damaged ¿ 2 syringes, incomplete scale markings ¿ 13 syringes.

Event Description

It was reported that syringe 1ml ll bns had scale marking issues on 13 occasions, foreign matter on 7 occasions, and was damaged on 2 occasions.The following information was provided by the initial reporter: deviations: brown, burned material ¿ 7 syringes.Missing stopper ¿ 1 syringe.Damaged ¿ 2 syringes.Incomplete scale markings ¿ 13 syringes.

Manufacturer Narrative

H.6.Investigation: twenty-three loose 1ml luer-lock syringes (p/n 309648) were received.The samples were visually evaluated.Seven samples were found to have an embedded brown foreign matter present on various areas of the barrel.The foreign matter appeared to be degraded plastic.One sample only had its barrel present and was missing a plunger-stopper assembly.Two samples were received with damage.One sample was observed to have a thick exterior scrape cutting through the "single use only" print.Additionally, a vertical scratch that did not fully penetrate the barrel wall could be seen on one sample ranging from the flange to just below the barrel step.This condition was cosmetic in nature and did not affect syringe function, thus being acceptable per product specification.Thirteen samples were received with scale marking issues claimed in the verbatim.All syringes had varying levels of scraping that rubbed part of the scale markings off.Nine of these samples were acceptable per product specification with the amount of print missing not enough to qualify as non-conforming.However, four from thirteen sample received had enough missing print to be considered non-conforming per product specification.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter 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.Potential root cause for the missing print defect is associated with the assembly process.Potential root cause for the missing components defect is associated with the assembly process.Potential root cause for the barrel damage is associated with the assembly process.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.

• Brand Name: SYRINGE 1ML LL BNS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12336875
• MDR Text Key: 267090982
• Report Number: 1213809-2021-00575
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309648
• Device Lot Number: 0059908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1