MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 1/2ML W/NDL 27X1/2 RB; PISTON SYRINGE

Catalog Number	305620
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 1/2ml w/ndl 27x1/2 rb contained foreign matter.The following information was provided by the initial reporter: "the customer states that they are finding that these syringes have fluid in them.Lot# 2355423" additional comments: n/a.Please see the attached quality report documenting a customer's allegation of a product deficiency.Your immediate attention and response to this quality report is required.Please perform a root cause analysis and corrective action plan, and report back to me with a letter of your findings within ten (10) business days.If a sample of the defective product is required for investigation, please provide the rma, the return address and collect carrier information within two (2) business days.If no direction is given, we will advise our customer to dispose of the goods.*in order to streamline customer communication, we ask that you please do not contact the customer directly unless requested to do so.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Pr (b)(4) follow up report for correction.The address/country was incorrect in the initial mdr.The initial reporter address is in canada and not the united states.
Additional Manufacturer Narrative
Investigation summary: 621 unused syringes of lot 2355423 were received by our quality team for investigation as well as 21 unused syringes of lot 6300942.There was also a photo provided by customer of a syringe with a fully seated stopper exhibiting a visual droplet at tip- this photo was enough to verify the customer's complaint of foreign matter.All syringes of lot 6300942 and 62 of lot 2355423 were tested by pushing stopper to fully seated position to try replicating the customer's photo.None of the 83 syringes presented with the droplets but when drawing air into syringes a little ring of silicone was occasionally noticed on the inside of the barrel.Silicone lubricant is employed during the syringe assembly process to help facilitate movement of the plunger and stopper.The silicone employed in this product is a medical grade silicone authorized for product use.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.The sample in customer's provided photo seemed to be slightly above our specified limits.This is not a safety hazard.The root cause of this instance is due to a slight over application of silicone from dispenser during syringe assembly.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue (batch#s: 2355423/6300942).
Event or Problem Description
Samples received.

• Brand Name: BD SYRINGE 1/2ML W/NDL 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18619222
• Report Number: 1920898-2024-00028
• Device Sequence Number: 19434563
• Product Code: FMF
• UDI-Device Identifier: 30382903056201
• UDI-Public: (01)30382903056201
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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
• Operator of Device: Other
• Device Catalogue Number: 305620
• Device Lot Number: 2355423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 01/11/2024; 07/17/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/03/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown