MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ PREFILLED HEPARIN LOCK FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306414

Device Problem Volume Accuracy Problem (1675)

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 309096n.D4.Medical device expiration date: 30sep2024.H4.Device manufacture date: 03apr2023.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd posiflush¿ prefilled heparin lock flush syringe the label was missing.There was no report of patient impact.The following information was provided by the initial reporter: one of our intern pharmacists was delivering the product into our pyxis machine on the inpatient floors.Product is not labeled correctly/no label is placed on the syringes.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-oct-2023.H6: investigation summary it was reported no label is placed on the syringes.To aid in the investigation, two samples in sealed packaging flow wraps and two photos were provided for evaluation by our quality team.A visual inspection was performed and both syringes have the barrel label missing.The two photos provided show the samples received.No other defects or imperfections were observed.This defect could occur during the manufacturing process if the strip with labels broke inducing the symptom reported.A device history record review was completed for provided material number 306414, possible lot numbers 309096n and 227348n.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Event Description

It was reported while using bd posiflush¿ prefilled heparin lock flush syringe the label was missing.There was no report of patient impact.The following information was provided by the initial reporter: one of our intern pharmacists was delivering the product into our pyxis machine on the inpatient floors.Product is not labeled correctly/no label is placed on the syringes.

• Brand Name: BD POSIFLUSH¿ PREFILLED HEPARIN LOCK FLUSH 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17848256
• MDR Text Key: 324638729
• Report Number: 1911916-2023-00711
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903064145
• UDI-Public: (01)30382903064145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090680
• 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,Followup
• Report Date: 10/02/2023

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: 306414
• Device Lot Number: 227348N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2022
• 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