MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 20ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Model Number 302830

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was performed for provided lot number 118546.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, 5 physical samples and one picture sample was received for evaluation by our quality team.Through examination of the physical samples, a visual inspection was preformed and all samples have missing scale markings.The picture shows the samples received with no scale marking and the packaging blister top web.The cause of this defect could have resulted during the syringe assembly printing process, during the barrel printing.The machine may have run low on ink and the barrels did not receive the scale markings and went undetected.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

Event Description

It was reported that prior to use with a bd 20ml syringe luer-lok¿ tip 4 syringes were missing scale markings.The following information was provided by the initial reporter: it was reported that multiple syringes did not have the markings.

• Brand Name: BD 20ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10611040
• MDR Text Key: 209845296
• Report Number: 1911916-2020-00911
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028307
• UDI-Public: 30382903028307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 302830
• Device Catalogue Number: 302830
• Device Lot Number: 0118546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other