MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT II 2 ML WITH 25G X 1; PISTON SYRINGE

Catalog Number 301866

Device Problems Unsealed Device Packaging (1444); Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

In this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.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 when using the bd discardit ii 2 ml with 25g x 1, the device experienced scale marking issues, damaged unit packaging where sterility is compromised and foreign matter within the fluid path.The following information was provided by the initial reporter.The customer stated: online rejection for marking defects, double needle, black spots and hair, blister leakage.

Event Description

It was reported when using the bd discardit ii 2 ml with 25g x 1, the device experienced scale marking issues, damaged unit packaging where sterility is compromised and foreign matter within the fluid path.The following information was provided by the initial reporter.The customer stated: online rejection for marking defects, double neelde, black spots and hair, blister leakage,.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned for the reported issue of ¿scale marking issue, foreign matter and package damage¿ with lot number 0214098 regarding item # 301866, so retention samples were used for the investigation.The dhr of material number 301866 with batch number 0214098 was checked and there were no quality notifications found.The investigation and simulation was carried out on ten retention samples where the investigating team has visually tested the samples and no scale marking issue, foreign matter or package damage was found in the ten retention samples.The investigating team could not confirm the reported defect.The root cause cannot be determined as there is no sample or photograph to investigate the defect.H3 other text : see h.10.

• Brand Name: BD DISCARDIT II 2 ML WITH 25G X 1
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13529542
• MDR Text Key: 287589361
• Report Number: 2243072-2022-00204
• 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: 03/03/2022

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: Other
• Device Catalogue Number: 301866
• Device Lot Number: 0214098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 03/03/2022
• Supplement Dates FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• 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