MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE CATHETER TIP 50ML; SYRINGE, IRRIGATING (NON DENTAL)

Catalog Number 309620

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

Materials#: 309620 batch#: 3139683.It was reported by the customer that a particulate on this 50 ml catheter tip syringe.Verbatim: rcc received a complaint via email.Email(s) attached.I am writing to report the presence of a particulate on this 50 ml catheter tip syringe.Compounding tech brought it to my attention.Cannot tell if it¿s in the sterile field or melted into the plastic.I no longer have the product in my possession.No patient involvement.Lot number: 3139683.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.(b)(4).Patient problem code: f27 ¿ no patient involvement.Device problem code: a180104 - device contamination with chemical or other material.

Manufacturer Narrative

(b)(4) follow up for device evaluation.It was reported there is the presence of a particulate on a syringe.To aid in the investigation, one sample with no packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed, and there is a brown speck of embedded degraded resin.The photo provided shows the sample received.No other defects or imperfections were observed.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.A device history record review was completed for provided material number 309620, lot 3139683.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Event Description

Pr (b)(4) additional information.Are you able to provide the dates of the events in the format of mm-dd-yyyy? 12-05-2023.Materials#: 309620 batch#: 3139683.It was reported by the customer that a particulate on this 50 ml catheter tip syringe.Verbatim: rcc received a complaint via email.Email(s) attached.I am writing to report the presence of a particulate on this 50 ml catheter tip syringe.Compounding tech brought it to my attention.Cannot tell if it¿s in the sterile field or melted into the plastic.I no longer have the product in my possession.No patient involvement.Lot number: 3139683.

• Brand Name: SYRINGE CATHETER TIP 50ML
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18397596
• MDR Text Key: 331683338
• Report Number: 1911916-2023-00913
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309620
• Device Lot Number: 3139683
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1