MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE; PISTON SYRINGE

Catalog Number 301001

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd discardit¿ ii syringe with detached bd microlance¿ needle the needle pulled from the hub.There was no report of patient impact.The following information was provided by the initial reporter: while using the discardit, staffs find difficulty to aspirate the blood and medications, finding bubbles in the syringe and needle coming out of the syringe while reconstituting the medication.

Manufacturer Narrative

The following field has been updated due to corrections: b.5.Describe event or problem: it was reported while using bd discardit¿ ii syringe with detached bd microlance¿ needle the needle separated from the syringe.There was no report of patient impact.

Event Description

It was reported while using bd discardit¿ ii syringe with detached bd microlance¿ needle the needle separated from the syringe.There was no report of patient impact.The following information was provided by the initial reporter: while using the discardit, staffs find difficulty to aspirate the blood and medications, finding bubbles in the syringe and needle coming out of the syringe while reconstituting the medication.

Event Description

On (b)(6) 2023 1.There is total 3 issues, please provide affected quantity for each issue affected quantity is not determined.2.Please provide date of occurrence as per the staffs, there were multiple occurrences happened during the first and second week of july.3.What is patient current condition? any serious injury? no serious issues with the patient.4.Any medical intervention provided? no 5.Were there air bubbles associated with the leakage? no 6.Any exposure to blood? uncertain 7.Any needle stick injury? no 8.Any picture/video? no.

Manufacturer Narrative

A device history record review was completed for provided material number 301001 and lot number 2212505.The review did not reveal any detected abnormalities during the production process that could have contributed to this reported incident.As samples were unavailable for return, twenty (20) retained samples were obtained from the manufacturing facility.However, the retained samples did not show any signs of defect upon evaluation.Although no issues were detected, it is possible that the reported incident resulted from damage to the barrel tip, which could occur during the manufacturing process or within assembly.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17492758
• MDR Text Key: 321320274
• Report Number: 3002682307-2023-00241
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903010011
• UDI-Public: (01)00382903010011
• 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: 08/16/2023

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: 301001
• Device Lot Number: 2212505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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