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

Catalog Number 306594

Device Problem Material Deformation (2976)

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

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported the drawbar is deformed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two prefilled syringes with a damaged plunger rod.No other defects or imperfections were observed.This defect could occur if these units were not placed in the correct position during flow wrapping.A device history record review was completed for provided material number 306594, lot 2096719.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The photo will be shown to associates for awareness.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

Event Description

It was reported that prior to use with 2 bd posiflush¿ syringe the plunger rods were discovered to be damaged.The following information was provided by the initial reporter, translated from chinese to english: the customer found that the drawbar was deformed when he took it out of the packaging box, and then he looked through the whole small package and found two products with the same quality problem.According to the hospital regulations, one penalty of ten was imposed if quality problems were found, so he contacted the agent, wondering whether it was caused by non-standard production and whether there would be other product problems, and asked the agent to give an explanation and compensation.The agent contacted the manufacturer and compensated 20 flush products for clinical use, and agreed that the department would provide comfort.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-jun-2023 h6: investigation summary it was reported the drawbar is deformed.To aid in the investigation, two samples with no packaging flow wrap and one photo was provided for evaluation by our quality team.A visual inspection was performed and both samples have a damaged plunger rod.The photo shows two prefilled syringes with a damaged plunger rod.No other defects or imperfections were observed.This defect could occur if these units were not placed in the correct position during flow wrapping and cutting.A device history record review was completed for provided material number 306594, lot 2096719.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.H3 other text : see h10.

Event Description

It was reported that prior to use with 2 bd posiflush¿ syringe the plunger rods were discovered to be damaged.The following information was provided by the initial reporter, translated from chinese to english: the customer found that the drawbar was deformed when he took it out of the packaging box, and then he looked through the whole small package and found two products with the same quality problem.According to the hospital regulations, one penalty of ten was imposed if quality problems were found, so he contacted the agent, wondering whether it was caused by non-standard production and whether there would be other product problems, and asked the agent to give an explanation and compensation.The agent contacted the manufacturer and compensated 20 flush products for clinical use, and agreed that the department would provide comfort.

• Brand Name: BD POSIFLUSH¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17159711
• MDR Text Key: 317945806
• Report Number: 1911916-2023-00419
• 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,Followup
• Report Date: 07/06/2023

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: 306594
• Device Lot Number: 2096719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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