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

Catalog Number 309657

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the plunger in the bd luer-lok¿ tip disposable syringe was loose and caused leakage during use.The following information was provided by the initial reporter: "certain syringes within cases wit lot 2215953 and 2301840 have been found to have loose plungers.When the syringe is filled with liquid and the needle is changed, the syringe is losing volume with no movement on the plunger.This is also being found where there is any slight movement on the plunger once liquid is drawn into the syringe (approximately 2+ ml).".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-jan-2023.H6: investigation summary five samples from batch 2215953 and five samples from batch 2301840 were provided to our quality team for investigation.A visual inspection was performed, and no defects or imperfections were observed.Each sample was tested for leakage past stopper and leakage at luer connection.All samples from batch 2215953 were passed both functional testing.However, one sample from batch number 2301840 was observed to have leakage past the first rib.Potential root cause for the leakage past stopper defect is associated with the assembly process.A device history record review was completed for provided batch numbers 2215953 and 2301840.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.

Event Description

Material no: 309657.Batch no: 2215953/ 2301840.It was reported that the customer was having issue with product.They have been found to have loose plungers.The syringe is losing volume with no movement on the plunger.Verbatim: certain syringes within cases wit lot 2215953 and 2301840 have been found to have loose plungers.When the syringe is filled with liquid and the needle is changed, the syringe is losing volume with no movement on the plunger.This is also being found where there is any slight movement on the plunger once liquid is drawn into the syringe (approximately 2+ ml).Customer having issues with item 309657 lot 2215953 what is the event date? 16dec22 what is the issue with the product? certain syringes within cases wit lot 2215953 and 2301840 have been found to have loose plungers.When the syringe is filled with liquid and the needle is changed, the syringe is losing volume with no movement on the plunger.This is also being found where there is any slight movement on the plunger once liquid is drawn into the syringe (approximately 2+ ml).Any patient harm due to reported issue? no ¿ this was found prior to patient interaction any medical intervention/ or treatment due to reported issue? no is the instrument available to send back to us for an evaluation? if so, a prepaid fedex label will be provided.This is usually only found once the liquid is drawn into the syringe and it is with random selection from the case.We can send back any syringes found to have loose plungers, however not all syringes with this issue are causing volume loss.Are there any photos available of the issue? n/a.

• Brand Name: BD LUER-LOK¿ TIP DISPOSABLE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16145162
• MDR Text Key: 308751550
• Report Number: 1213809-2023-00003
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096572
• UDI-Public: 00382903096572
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309657
• Device Lot Number: 2301840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1