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

Catalog Number 300850

Device Problem Leak/Splash (1354)

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

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is bawal, india.This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2155981.Medical device expiration date: 31-may-2027.Device manufacture date: 04-jun-2022.Medical device lot #: 2155982.Medical device expiration date: 31-may-2027.Device manufacture date: 04-jun-2022.Initial reporter phone#: unknown.Initial reporter e-mail: unknown.Investigation summary: there are no samples and three photographs along with the reported complaint of leakage.The investigating team has used the retention samples of material number 300852 and lot number 2155981 & 2155982 for investigating the reported defect.The investigation and simulation were carried out on retention samples where the investigating team has functionally tested the samples for leakage and no leakage was found in the retention samples.The investigation was also carried out on the photograph as well.The photograph confirms the reported defect of leakage, but the root cause could not be determined based on the photograph.Based on the photograph the leakage is confirmed as there is visible blood flowing backwards after the plunger.This leakage could be a one of case where the plunger tip may be damaged or has a dent.The probable root cause can only be determined after investigating the original sample.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Event Description

It was reported that at least one bd discardit¿ ii syringe each from lots 2155981 and 2155982 leaked blood past their plunger stoppers while aspirating it.The following information was provided by the initial reporter: "the customer is facing frequent leakage problem from the gap between barrel and plunger of the syringe while withdrawing blood.This is resulting in the loss of volume of blood sample and exposing healthcare worker to blood.The extent of leakage is different with different defected syringes.".

• Brand Name: BD DISCARDIT¿ II 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15525179
• MDR Text Key: 301744733
• Report Number: 2243072-2022-01705
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903008506
• UDI-Public: (01)00382903008506
• 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,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2022

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: 300850
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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