MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 30ML LL BNS; SYRINGE, PISTON

Catalog Number 301033

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2019

Event Type  malfunction  

Event Description

Material #:301033, batch#:unknown.It was reported by customer that the plunger separated from barrel of syringe.Verbatim: rcc received a complaint via email.Email(s) attached.Medline complaint #: (b)(6).Defect description: plunger separated from barrel of syringe.Medline part #: 33239.Product description: syr 30ml l/l.Vendor part #: 301033.Lot #: unknown.Date reported: 08/05/2019.Sample received: no.Response needed: summary of findings and corrective action complaint reported to fda as mdr-30 day.Reference no.1423395-2024-00060.

Manufacturer Narrative

(b)(4): initial mdr submission with device evaluation.As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.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.

• Brand Name: SYRINGE 30ML LL BNS
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18972757
• MDR Text Key: 339084967
• Report Number: 1911916-2024-00213
• Device Sequence Number: 1
• Product Code: FMF
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301033
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1