MAUDE Adverse Event Report: BECTON DICKINSON DISCARDITII 2ML WITH 24X1; SYRINGE

Catalog Number 300844

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and (b)(4) fda registration number has been used for the manufacture report number.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 that discarditii 2ml with 24x1 was used and the patient are developed sepsis.This occurred on 8 occasions.The following information was provided by the initial reporter: 1) the doctor called me yesterday evening and said that after using the product the patients are developing sepsis and he returned 2 boxes of discardit to the supplier.

Event Description

It was reported that discarditii 2ml with 24x1 was used and the patient are developed sepsis.This occurred on 8 occasions.The following information was provided by the initial reporter: 1) the doctor called me yesterday evening and said that after using the product the patients are developing sepsis and he returned 2 boxes of discardit to the supplier.

Manufacturer Narrative

H6: investigation summary the photos were received by bd for evaluation.A quality engineer was able to review the photos of a discardit 2ml from lot # 1138362 regarding item # 300844 with the reported issue that ¿after using the product the patients are developing sepsis and he returned 2 boxes of discardit to the supplier.After usage of the syringe, the patients are developing sepsis¿.The dhr of material number 300844 and lot number 1030341 was checked and no quality notification was recorded on this lot.We also checked for the sterility records and the bi of the reported lot number in the dhr and the sterility records were found to be within bd specifications.No sample and three photographs were received from the customer and were used for investigation of the reported defects.The investigation team also used retention samples of material code 300844 and lot number 1030341 for investigating the reported defect.None of the ten retention samples showed any breach of sterility or sealing breach in them.The investigation on the photographs received from the customer were unable to help in confirming the defect reported by the customer.The defect is not confirmed.The probable root cause could not be determined as all packed syringes are sterilized and the sterilization cycle is validated for its effectiveness based on the standards laid down by the regulatory bodies.We also have a microbiology laboratory that follows the stringent regulations laid down on medical devices regulatory authorities.

• Brand Name: DISCARDITII 2ML WITH 24X1
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12638792
• MDR Text Key: 276590539
• Report Number: 2243072-2021-02509
• Device Sequence Number: 1
• Product Code: FMF
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 300844
• Device Lot Number: 1138362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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
• Patient Outcome(s): Other