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

Catalog Number 309050

Device Problem Leak/Splash (1354)

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

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 discardit¿ ii syringe leaked.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "this complaint is to report the issue with the 5ml syringes.Stuck plunger, air entry."we have had several complaints from customers regarding bd brand 10ml and 20ml syringes.They complain of stuck plungers, air entry, and if they do not place the syringe in an upright position when positioning the syringe towards the collection tube there are several drips on the floor."".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 07-aug-2023.H6: investigation summary a device history record review was completed for provided material number 309050 and lot number 2209184.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) picture sample and four (4) physical samples were returned for evaluation by our quality engineer team.The physical samples were reviewed; however, no signs of defect were observed.The provided physical samples did not display any functionality issues and the samples met all specifications and standards.On the other hand, the medication used by the customer or a special method of use (high temperatures, pressures, several uses, etc.) could affect the sliding properties of the syringes.Through inspection of the picture sample, leakage could be observed within the syringe.The leakage displayed in the picture could have resulted from damage in the plunger lip component.This type of damage may occur during the handling of the product through the manufacturing process or within the plunger assembly machine.

Event Description

It was reported that the bd discardit¿ ii syringe leaked.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "this complaint is to report the issue with the 5ml syringes.Stuck plunger, air entry."we have had several complaints from customers regarding bd brand 10ml and 20ml syringes.They complain of stuck plungers, air entry, and if they do not place the syringe in an upright position when positioning the syringe towards the collection tube there are several drips on the floor."".

• Brand Name: BD DISCARDIT¿ II SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17000077
• MDR Text Key: 315931029
• Report Number: 3002682307-2023-00137
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309050
• Device Lot Number: 2209184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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