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 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Investigation summary: it was reported the batch number of the large package and the batch number of the medium package were found inconsistent in the warehouse.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows the case box label and the other photo shows the shelf box label.The shelf box label has the lot number in two areas.One area is at the bottom right corner and the other area is at the middle of the bar code.The bottom right corner lot number is missing the last three digits, but the middle bar code has the complete lot number.It could be possible the shelf box printer head became clogged 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 label printing process was performed.The printing was correct and the printing head was clean.The flow of products and shelf boxes was acceptable.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is 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 2400 bd posiflush¿ normal saline syringes had incorrect label information.The following information was provided by the initial reporter: "a total of 2400 flush¿s batch number of the large package and the batch number of the medium package were found inconsistent in the warehouse.".

• 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: 12703039
• MDR Text Key: 278579989
• Report Number: 1911916-2021-01109
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/27/2021
• 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