MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ SYRINGE WITH BD LUER-LOK¿ TIP; HYPODERMIC SYRINGE

Catalog Number 302830

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.No lot # provided.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 during use that the black stopper separated from the bd¿ syringe with bd luer-lok¿ tip plunger when drawing up ivf.No serious injury or medical intervention noted.

Manufacturer Narrative

A sample was returned to the columbus plant for evaluation.The stopper was removed from the plunger rod verifying the failure mode.Rolled stoppers can occur intermittently during assembly of the syringe when the plunger rod and stopper subassembly are pressed into the syringe barrel.A misalignment between the barrel and subassembly can cause the rolled stopper or not properly attached to plunger rod.Cameras were implemented to detect rolled stoppers during the manufacturing process.Syringes determined to be defective are automatically rejected by the machinery.The camera is challenged every shift to ensure it is functioning as intended.A dhr could not be completed as the lot number was unknown.

• Brand Name: BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: HYPODERMIC 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 ; 8015652845
• MDR Report Key: 7192168
• MDR Text Key: 97664910
• Report Number: 1911916-2017-00407
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903028306
• UDI-Public: 00382903028306
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302830
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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