MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ SP SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306574

Device Problem Missing Information (4053)

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

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd posiflush¿ sp syringe barrel label was missing the scale markings and lot information.The following information was provided by the initial reporter: "the product envelope torn = 2 sp and the product envelope torn and no lot = 1 sp".

Manufacturer Narrative

H.6.Investigation summary: a device history record review was completed for provided material number 306574 and lot number 2327524.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, twelve (12) pictures were received for evaluation by our quality team.Through examination of the pictures, several syringes were observed with packaging film torn at the plunger areas and a syringe was observed without a barrel label.It is possible that the torn film packages resulted from a defect with the spikes that perforate the film.If the unit package perforation is not well adjusted, the perforation becomes too large and may result in tearing when the syringes are placed within the shelf carton.This defect may also occur if the transversal sealing is too short.The production process has a vision system in place to detect missing barrel labels.In this case a failure occurred in the vision system.If the syringe has no label and the rejection system fails, the station stops and does not allow the machine to run.The operator must check to see the cause of the stoppage and resolve the issue.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

It was reported that the bd posiflush¿ sp syringe barrel label was missing the scale markings and lot information.The following information was provided by the initial reporter: "the product envelope torn = 2 sp and the product envelope torn and no lot = 1 sp.".

• Brand Name: BD POSIFLUSH¿ SP SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17482309
• MDR Text Key: 321228143
• Report Number: 3002682307-2023-00231
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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 Catalogue Number: 306574
• Device Lot Number: 2327524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• 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