MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGES,; SALINE, VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: address information was not able to be obtained, therefore, nj was used as a place holder.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 while using bd posiflush¿ normal saline syringes, the plunger movement was difficult.There was no report of patient impact.The following information was provided by the initial reporter: "impossible to push the plunger down even after you break the seal to get all of the air out".

Manufacturer Narrative

H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 2151807.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

Event Description

It was reported while using bd posiflush¿ normal saline syringes, the plunger movement was difficult.There was no report of patient impact.The following information was provided by the initial reporter: "impossible to push the plunger down even after you break the seal to get all of the air out".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGES,
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16191505
• MDR Text Key: 307572655
• Report Number: 1911916-2023-00004
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

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 Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 2151807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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