MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB; PISTON SYRINGE

Model Number 305905

Device Problem Illegible Information (4050)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported there was blue taping on the packaging.To aid in the investigation, three photos were provided for evaluation by our quality team.Each photo shows a packaging blister being opened.The packaging blister top web has a blue line from the top to bottom at one of the edges.All the information printed on the top web is legible so this is acceptable.A device history record review was completed for provided material number 305905, lot number 1021251.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the photo sample analysis the foreign matter symptom reported by the customer could not be confirmed.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.

Event Description

It was reported that the syringe 3ml ll w/ndl sftygld 23x1 rb experienced unclear packaging/labeling.The following information was provided by the initial reporter: suspected contamination plus unclear label printing.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
• 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: 12132526
• MDR Text Key: 261064326
• Report Number: 1911916-2021-00647
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059059
• UDI-Public: 30382903059059
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305905
• Device Catalogue Number: 305905
• Device Lot Number: 1021251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• 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