MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRE-FILLED NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306593

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the 1st complaint for lot # 9206061 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Based on the investigation carried out and with no sample for analysis the symptom reported by the customer can¿t be confirmed.No additional actions will be taken other than monitoring the complaint trend for this lot.This lot was produced for 1.38mm units; therefore, the cpm is 0.7 root cause description: no root cause can be determined as no samples were received.Rationale: capa not required at this time.A review of the applicable fmea/eura (arm208/rev#17) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.

Event Description

It was reported that the bd¿ pre-filled normal saline syringe plunger was found broken before use when opening up the packaging.The following information was provided by the initial reporter, translated from (b)(6) to english: "the patient was admitted to the hospital on (b)(6) 2009 due to accidental administration of antihypertensive drugs.After the infusion, it was sealed with a flush for the child patient.After the package was opened, the plugger handle was broken and replacement of a new flush to seal the tube.".

• Brand Name: BD PRE-FILLED 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10370202
• MDR Text Key: 203168754
• Report Number: 1911916-2020-00715
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 306593
• Device Lot Number: 9206061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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
• Patient Outcome(s): Other