MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE; INTRAVASCULAR CATHETER

Catalog Number 306574

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

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 56 bd posiflush¿ iv flush solution sodium chloride had missing label information.The following information was provided by the initial reporter: "box tear inside carton.".

Manufacturer Narrative

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 56 bd posiflush¿ iv flush solution sodium chloride had missing label information.The following information was provided by the initial reporter: "box tear inside carton.".

Event Description

It was reported that 56 bd posiflush¿ iv flush solution sodium chloride had missing label information.The following information was provided by the initial reporter: "box tear inside carton.".

Manufacturer Narrative

H6: investigation summary: a device history record review was completed for provided material number 306574 and lot number 1152011.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, picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, damaged shelf cartons were observed.There were several samples which presented holes and poor package integrity.The case cartons seemed to be in good condition.All lots produced are checked prior to loading for product integrity.The packing lists were reviewed and no issues with loading records were found for the lot in question.An exact cause related to the manufacturing process could not be determined for the observed damage.

• Brand Name: BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE
• Type of Device: INTRAVASCULAR CATHETER
• 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 ; 8015296192
• MDR Report Key: 13120586
• MDR Text Key: 285547783
• Report Number: 3002682307-2021-00672
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 03/07/2022

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 306574
• Device Lot Number: 1152011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 03/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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