MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE; FLUSH

Catalog Number 306593

Device Problems Material Discolored (1170); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the defective device was received sealed with flow wrap packaging.The barrel label confirms the batch# 6144509.The saline shows a discoloration, the plunger-stopper was removed and the rubber stopper inspection shows that it has embedded fm.This fm induced the discoloration as a reaction with the saline solution.Conclusion: although the customer's reported defect was confirmed, an absolute root cause for this incident cannot be determined.Udi#: (b)(4).

Event Description

It was reported that the 3 ml bd¿ pre-filled syringe, normal saline, was brown in the package.There was no report of injury or medical interventions.

• Brand Name: 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE
• Type of Device: 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 ; 8015652845
• MDR Report Key: 6740987
• MDR Text Key: 81129183
• Report Number: 1911916-2017-00135
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 306593
• Device Lot Number: 6144509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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