MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK; PISTON SYRINGE

Model Number	309701
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to use foreign matter was discovered in sterile syringe tray with a bd 1 ml syringe luer slip tip convenience pak.The following information was provided by the initial reporter: it was reported that a foreign substance was found in one of the customers sterile syringes trays.
Additional Manufacturer Narrative
Investigation: one convenience tray of twenty-five syringes was provided for investigation by our quality engineer team.Through examination of the returned sample, foreign matter was identified within the tray.Fourier transform infrared spectroscopy (ftir) analysis was performed on the foreign matter.The ftir analysis results indicated that the foreign matter was ink.As the convenience tray lids are printed, they move down a conveyor.Ink residue was found to accumulate at the end of the printing machine's conveyor.Ink residue was found to accumulate at the end of the printing machine's conveyor.When the lid involved in this incident came into contact with the end of the conveyor, it became contaminated with ink residue.This defect was undetected during the production process of lot number: 9213387, as all inspected product was found to be within specification.A preventive maintenance plan has been initiated to prevent this defect from recurring.
Event or Problem Description
It was reported that prior to use foreign matter was discovered in sterile syringe tray with a bd 1 ml syringe luer slip tip convenience pak.The following information was provided by the initial reporter: it was reported that a foreign substance was found in one of the customers sterile syringes trays.

• Brand Name: BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9365489
• Report Number: 9610847-2019-00697
• Device Sequence Number: 14353528
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 11/30/2023
• Device Model Number: 309701
• Device Catalogue Number: 309701
• Device Lot Number: 9213387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/27/2020
• 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