MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY; PISTON SYRINGE

Model Number	309701
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that 8 bd luer-lok¿ syringes in the bulk sterile pharmacy convenience trays were found with "illegible" scale markings and foreign matter in them before use.The following information was provided by the initial reporter: "particulate found on the inside as well as illegible graduation marks.".
Additional Manufacturer Narrative
H.6.Investigation: eleven picture samples were received for evaluation by our quality engineer team.Through examination of the picture samples, four syringes were observed with single foreign matter particles within the barrel walls of the syringe and three of the syringes had small black particles on the external surface of the syringe.The black particles were determined cosmetic defects and acceptable per product specifications.One of the syringes was observed to have the word "embedded" written on it and it had a small brown particle outside the scale markings.Four syringes were observed to have scale marking defects; of the four, three syringes had smeared illegible printed gradient lines and one syringe had high density illegible printed gradient lines.These defects were not detected prior to packaging.It was determined that the embedded foreign matter was most likely degraded plastic, which results when resin is exposed to high temperatures within the molding machine.Per procedure, all molding equipment should be cleaned for degraded plastic, however, this type of defect is cosmetic only and does not pose a risk to the customer.The scale marking defects resulted from a print defect within the scale marking process.Based on dhr review for material 309701 with lot number 9127543 met the assembly specifications and qa inspections.
Event or Problem Description
It was reported that 8 bd luer-lok¿ syringes in the bulk sterile pharmacy convenience trays were found with "illegible" scale markings and foreign matter in them before use.The following information was provided by the initial reporter: "particulate found on the inside as well as illegible graduation marks.".

• Brand Name: BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
• 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: 9521191
• Report Number: 9610847-2019-00765
• Device Sequence Number: 2756656
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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: 08/31/2023
• Device Model Number: 309701
• Device Catalogue Number: 309701
• Device Lot Number: 9127543
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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