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

Catalog Number	309645
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that two of the bd luer-lok ¿ syringes were found without lot numbers and expiration dates before use.There was no report of exposure, injury, or medical intervention noted.
Event or Problem Description
It was reported that two of the bd luer-lok ¿ syringes were found without lot numbers and expiration dates before use.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: one photo depicting three 10ml packaged syringes with needle.The batch # and expiration date are printed on the top web for one syringe.The other two packages have missing / illegible batch # and expiration date on the top web.Missing/illegible batch # or expiration date on top web is rejectable per product specification.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.Potential root cause for the missing information defect is associated with the top web printer.During printer restart the first machine advance will not print completely.This requires manual removal of the first few packages with no print.It is likely in this case the strip of packages was not removed.No corrective actions are necessary based on the defective rate identified.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.

• Brand Name: BD LUER-LOK ¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7720894
• Report Number: 1213809-2018-00496
• Device Sequence Number: 1754131
• Product Code: FMF
• UDI-Device Identifier: 30382903096450
• UDI-Public: 30382903096450
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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
• Operator of Device: Other
• Device Catalogue Number: 309645
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other