MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364314

Device Problems Melted (1385); Packaging Problem (3007)

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

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for deformed plunger stopper was observed.The failure mode of missing needle shield was not observed from the photos.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode deformed plunger stopper.This complaint has been unconfirmed for the failure mode missing needle shield.Bd determined that the root cause of the deformed plunger stopper was attributed to worn manufacturing equipment as well as interfering parts within the manufacturing process.Several corrective actions are being put in place which include repositioning equipment and replacing worn parts.The process will continue to be reviewed after corrective actions have been completed.Bd was not able to identify a root cause for the missing needle shield.

Event Description

It was reported when unpacking the bd preset¿ syringes with attached needles there was deformed plungers and sterility issues.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "when unpacking, two of the plunger stoppers were melted and one needle shield was missing.".

• Brand Name: BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14119345
• MDR Text Key: 289456155
• Report Number: 9617032-2022-00365
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022426
• 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
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 364314
• Device Lot Number: 1197895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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