MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ SP; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306574

Device Problem Fungus in Device Environment (2316)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

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 270 boxes of bd posiflush¿ sp syringes had a mold/mildew odor.The following information was provided by the initial reporter: "customer says that our delivery boxes smelled like mildew.That they were trying to figure out where the mold smell was coming in their ware house.But they figure out, it was our boxes when one of their patient send back a box of posiflushes because the box smelled so badly to mildew.".

Event Description

It was reported that 270 boxes of bd posiflush¿ sp syringes had a mold/mildew odor.The following information was provided by the initial reporter: "customer says that our delivery boxes smelled like mildew.That they were trying to figure out where the mold smell was comming in their ware house.But they figure out, it was our boxes when one of their patient send back a box of posiflushes because the box smelled so badly to mildew.".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided lot number 0329496.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.As samples were unavailable for return, retained samples of the same lot number were obtained for further evaluation.The retained samples were tested for sterility.The test results showed no microbiological growth to support the complaint of odor.The posiflush product is loaded directly into the containers and therefore there is no possibility of the product being affected by humidity in the warehouse.Product is not stored within the manufacturing facility, so there is no risk of ambient conditions affecting the product or package integrity.Based on the investigation results, a cause related to the manufacturing process cannot be determined for the reported incident.This is a very unusual circumstance.All processes that could have affected the sterility of the product were reviewed and no issues were detected.

• Brand Name: BD POSIFLUSH¿ SP
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12340610
• MDR Text Key: 267234830
• Report Number: 3002682307-2021-00418
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 10/21/2021

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 306574
• Device Lot Number: 0329496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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