MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY; PISTON SYRINGE

Catalog Number	309701
Medical Device Problem Codes	Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Material no.309701, batch no.8256581.It was reported that before use of the bd luer-lok¿ syringe bulk sterile pharmacy convenience tray there were eleven issues.Six were found with different types of foreign matter contaminants, four had missing plungers, and one was found with a scale marking issue.The following information was provided by the initial reporter: i am the quality assurance specialist we have discovered eleven issues from the last six months of this year.Six empty 1ml bd syringe -slip tip tray were found with different types of contaminants four empty 1ml bd syringe -slip tip in tray were found without plungers in the syringes barrel one empty 1ml bd syringe -slip in tip tray was found with a graduated marking defect.
Event or Problem Description
Material no.309701, batch no.8256581.It was reported that before use of the bd luer-lok¿ syringe bulk sterile pharmacy convenience tray there were eleven issues.Six were found with different types of foreign matter contaminants, four had missing plungers, and one was found with a scale marking issue.The following information was provided by the initial reporter: i am the quality assurance specialist we have discovered eleven issues from the last six months of this year.Six empty 1ml bd syringe -slip tip tray were found with different types of contaminants.Four empty 1ml bd syringe -slip tip in tray were found without plungers in the syringes barrel.One empty 1ml bd syringe -slip in tip tray was found with a graduated marking defect.
Additional Manufacturer Narrative
H.6.Investigation: one loose 1ml syringe was received and evaluated.It was observed there was a brown foreign matter substance outside the fluid path, attached to the bottom of the plunger rod near the stopper.It appeared to be oil and was larger than level 3 in size, which was rejectable per product specification.The plunger rod was from mold c-220 cavity 51.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.Potential root cause for the foreign matter defect is associated with the molding process.The oil found on the syringe is most likely oil from the molding machines used for lubrication.

• Brand Name: BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8755788
• Report Number: 1213809-2019-00695
• Device Sequence Number: 1541588
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 309701
• Device Lot Number: 8256581
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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