MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT¿ SYRINGE; PISTON SYRINGE

Catalog Number 302438

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.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 that 48 bd discardit¿ syringes had scale marking defects/missing scale markings.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "marking defects".

Manufacturer Narrative

H.6.Investigation: the photos were received by bd for evaluation.A quality engineer was able to review the photos of a discardit 2ml with 25gx1 from lot # 1136652 regarding item # 302438 with the reported issue of ¿online rejection for marking defects, double needle, black spots, blister leakage, hair¿.The dhr of material number 302438 and lot number 1136652 was checked and no quality notifications were recorded on this lot.No samples and ten photographs were received from the customer and were used for investigation of the reported defects.The investigating team also used the retention samples of material code 302438 and lot number 1136652 for investigating the reported defect.There are multiple defects reported in this complaint.There is a capa no 2448117 opened on this defect for this product which is under effectiveness check currently in progress.

Event Description

It was reported that 48 bd discardit¿ syringes had scale marking defects/missing scale markings.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "marking defects.".

• Brand Name: BD DISCARDIT¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12865308
• MDR Text Key: 285933796
• Report Number: 2243072-2021-02802
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302438
• Device Lot Number: 1136652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2021
• 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