MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306595

Device Problem Missing Information (4053)

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

Event Date 10/25/2021

Event Type  malfunction  

Event Description

It was reported when using the bd posiflush¿ normal saline syringe there was no label or missing label information.This event occurred with 1350 devices.The following information was provided by the initial reporter.The customer stated: "in the warehouse, the batch number of flush medium packaging (30 pieces for one medium packaging) was not fully printed, and the last two pieces of batch number were not printed.1350 pieces in total, were affected.".

Manufacturer Narrative

Investigation summary: it was reported the batch number was not fully printed.To aid in the investigation, three photos were provided for evaluation by the quality team.One photo shows a human hand showing the syringe barrel label.The second photo shows a case label.There are no defects or imperfections observed in these photos.The third photo shows a shelf box label that has the batch number partially printed.The batch number is missing the last two digits.This defect could occur if the shelf box printer run had a variation inducing the symptom reported by the customer.A device history record review was completed for provided material number 306595, lot number 1085214.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the shelf box labeling process was performed.No issues or variations were detected and associates were made aware of this complaint.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• 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: 12856065
• MDR Text Key: 285690105
• Report Number: 1911916-2021-01175
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 306595
• Device Lot Number: 1085214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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