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

Catalog Number 306595

Device Problem Break (1069)

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

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 2034419.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.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd posiflush¿ normal saline syringe experienced a damaged plunger rod.The following information was provided by the initial reporter: the patient was diagnosed with small cell carcinoma of the upper lobe of the right lung for 3 months.Admitted at 08:31 on (b)(6) 2022.After admission, the picc catheter was pulsed flush for chemotherapy.Before pulse flushing, the patient opened the package and found that part of the needle plug was missing and the injection could not be pushed.Stopped immediately and replace with a new one customer suspected that some part of the product needle plug was missing during the delivery process and could not be injected.The specific defect is the breakage of the pin rather than the loss of the pin.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• 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: 15888288
• MDR Text Key: 307891435
• Report Number: 1911916-2022-00682
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306595
• Device Lot Number: 2034419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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