MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 30ML LL S/C 56; PISTON SYRINGE

Catalog Number 302832

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: a device history record review was completed for provided material number 302832 and lot number 0044896.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one hundred forty-one samples were received for evaluation by our quality team.A visual inspection was performed and the scale marking is missing.No other defects or imperfections were observed.Investigation conclusion: based on the investigation with the returned sample analysis the symptom reported by the customer is confirmed.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Root cause description: it could be possible for this defect to occur if the printing bad did not have enough pressure inducing the missing scale marking.Rationale: capa not required at this time.

Event Description

It was reported that syringe 30ml ll s/c 56 had no scale markings.This occurred on 4 occasions.The following information was provided by the initial reporter: material no: 302832, batch no: 0044896.It was reported no markings on syringes.

• Brand Name: SYRINGE 30ML LL S/C 56
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11389259
• MDR Text Key: 233974869
• Report Number: 1911916-2021-00172
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: 00382903028320
• 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: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302832
• Device Lot Number: 0044896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• 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