MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306594

Device Problem Missing Information (4053)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

(b)(6) 2024 patient infusion end of indwelling needle sealing tube, found pre-filled without marking, no date of manufacture, immediately given a replacement, did not cause adverse consequences.

Manufacturer Narrative

Pr (b)(4) follow up.It was reported a prefilled syringe without markings was found.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a prefilled syringe with no packaging flow wrap or syringe barrel label.No other defects or imperfections were observed.This defect could occur if there was a jam during the syringe barrel label process.A device history record review was completed for provided material number 306594, lot 3178581.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.Verification of the syringe barrel labeling process was performed.The settings were correct, and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

Event Description

No additional information received.On (b)(6) 2024 patient infusion end of indwelling needle sealing tube, found pre-filled without marking, no date of manufacture, immediately given a replacement, did not cause adverse consequences.

• Brand Name: SYRINGE 5ML SALINE FILL CHINA SP
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• 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: 19133697
• MDR Text Key: 340491194
• Report Number: 1911916-2024-00269
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065944
• UDI-Public: (01)30382903065944
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 306594
• Device Lot Number: 3178581
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1