MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK SYRINGE

Catalog Number 303064

Device Problems Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)

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

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 bd luer-lok¿ syringe had particles inside the package as well as syringe.Customer¿s verbatim: "particles found inside the packing as well as syringe in closed pack( not opened).Small pores observed in the upper cover".

Manufacturer Narrative

Investigation summary: a device history record review found no non-conformances associated with this issue during production of this batch.Sample evaluation: 4 actual samples returned in sealed packaging was returned for evaluation.The team had observed holes on the bottom web and particles inside the package.The black particles which could be sand particles were observed inside the syringe product and at the corner of the blister packaging.The team had observed holes on the bottom web and particles inside the package.Hence, we confirmed the customer experience.Conclusion: the team had reviewed the in-process and outgoing inspection records and black/sand particles were not detected.The black/sand particles could have been brought into the syringe package when the pest/insect bites the bottom web to enter the packaging.The team had also reviewed the pest control records and no abnormalities were detected at the 10ml manufacturing line.Hence, we are unable to identify the root cause of the reported nonconformance.The nonconformance could have occurred out of the manufacturing facility.The team will continue to monitor this non-conformance.

Event Description

It was reported that bd luer-lok¿ syringe had particles inside the package as well as syringe.Customer¿s verbatim: ¿ particles found inside the packing as well as syringe in closed pack( not opened).Small pores observed in the upper cover ¿.

• Brand Name: BD LUER-LOK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8465933
• MDR Text Key: 140737035
• Report Number: 8041187-2019-00265
• Device Sequence Number: 0
• Product Code: FMF
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 303064
• Device Lot Number: 8285041
• Date Manufacturer Received: 03/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other