MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 30 ML BD LUER-LOK TIP SYRINGE; PISTON SYRINGE

Catalog Number 302832

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: as the lot provided for this complaint is 'unknown,' a device history record review could not be completed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a syringe with a red solution in it.The area of the rubber stopper has a hand drawn yellow circle.From the photo there is no solution that has past the rubber stopper or is it possible to observe any solution between the rubber stopper ribs.Based on the investigation results, the sample received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for this product and symptom.Probable root cause is unknown.

Event Description

It was reported that the 30 ml bd luer-lok¿ tip syringe experienced leakage.The following information was provided by the initial reporter: drug leaked past stopper.

• Brand Name: 30 ML BD LUER-LOK TIP SYRINGE
• Type of Device: PISTON SYRINGE
• 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 ; 8015296192
• MDR Report Key: 11103499
• MDR Text Key: 225804688
• Report Number: 1911916-2020-01163
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: 00382903028320
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K980987
• 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: 12/15/2020

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: 302832
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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