MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD; ANTISTICK SYRINGE

Catalog Number 47531202

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is le pont de claix.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in the franklin lakes fda registration number has been used for the manufacture report number.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 the bd ultrasafe plus¿ passive needle guard plunger rod was loose and caused fluid to leak out from the back.The following information was provided by the initial reporter: "took the syringe in her hand, the syringe started to leak from the back side at the plunger, and she did not have the chance to press on it.I confirm the complaint defect item after reading the description is plunger rod, which was loose and felt from the syringe causing leakage of the medicine from the syringe and patient was unable to complete the injection.".

Manufacturer Narrative

Investigation summary on may 9th, 2023, the customer novartis raised a complaint for one loose plunger rod detected during the use on the market, which would have caused a drug's leakage.Three picture evidences were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis on may 17th, 2023, but no physical sample.The pictures show both plunger components (plunger rod and plunger stopper) outside of the syringe barrel.Based on provided pictures, there is no obvious damage or defect on the plunger rod (such as flash, burn marks, scratch.) and the plunger rod is not detached from the plunger stopper.More precisely, the plunger rod seems to be properly screwed in the stopper.The reported batch 2082526 is a parent batch manufactured at bdm-ps approved supplier in january 2021.(b)(4) units were manufactured, and the full batch was shipped to novartis.Bd molding supplier performed a batch history record¿s (bhr) review and did not identify any non-conformance or specific event related to the reported condition.The batch involved in this complaint meets all acceptable quality levels (aql¿s), was manufactured and released according to applicable procedures and specifications.As a reminder, the component which ensures an airtight seal to the syringe is the plunger stopper, not the plunger rod, by fitting tightly inside the barrel.Out of the conducted investigation, bdm-ps is not able to correlate the reported condition with a potential cause linked to bd plunger rod manufacturing process.As a consequence, bdm-ps does not propose corrective or preventive action in the scope of this complaint.

Event Description

It was reported that the bd ultrasafe plus¿ passive needle guard plunger rod was loose and caused fluid to leak out from the back.The following information was provided by the initial reporter: "took the syringe in her hand, the syringe started to leak from the back side at the plunger, and she did not have the chance to press on it.I confirm the complaint defect item after reading the description is plunger rod, which was loose and felt from the syringe causing leakage of the medicine from the syringe and patient was unable to complete the injection.".

• Brand Name: BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD
• Type of Device: ANTISTICK 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 ; 8448235433
• MDR Report Key: 17048925
• MDR Text Key: 316390835
• Report Number: 2243072-2023-00940
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47531202
• Device Lot Number: 2082526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2021
• 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