MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL BNS; PISTON SYRINGE

Catalog Number 301027

Device Problems Volume Accuracy Problem (1675); Fitting Problem (2183); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: thirteen loose 5ml syringes (p/n 301027) were received.The samples were visually evaluated.Ten samples that were identified in the verbatim as having "ink dots" were observed to be cylinder dots and acceptable per product specification.One sample was missing its stopper entirely.One sample had illegible and smeared print where the bd logo should be and ink smearing outside of the print area.One sample was identified as having "pollution/dirt" per.It was observed that the foreign matter was not dirt, but ink from the printing process which had smeared outside of the print area.The black dots next to the grad lines are used to monitor the etchings on the print cylinder.Each cylinder has three etchings that become filled with ink and are printed onto each barrel.The dots are used to indicate which etching was used.One etching has no dots, one has one dot, and one has two dots.Batches #0026180 and #0195365 are considered in compliance with our product specification requirements.Furthermore, 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.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: potential root cause for the ink smearing defect is associated with the marking process.Potential root cause for the missing stopper defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Rationale: capa not required at this time.

Event Description

It was reported that syringe 5ml ll bns had foreign matter, scale marking issues, and loose plunger.The following information was provided by the initial reporter: 1 syringe with pollution/dirt.1 syringe poorly printed.1 syringe with loose plunger and missing end top.10 syringes with ink dots.

• Brand Name: SYRINGE 5ML LL BNS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12163189
• MDR Text Key: 266874455
• Report Number: 1213809-2021-00491
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301027
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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