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

Catalog Number 306595

Device Problem Crack (1135)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ normal saline syringe was damaged, cracked.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, when the patient finished the fluid infusion and the nurse closed the indwelling needle for the patient, it was found that the pre-filled catheter irrigator had a crack in the wall of the syringe and leakage, and the pre-filled catheter irrigator was replaced in time without causing harm.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: it was reported the pre-filled irrigator had a crack in the wall.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a prefilled syringe in an opened packaging flow wrap.The syringe barrel has a line that appears to be the crack reported.The line goes from the bottom of the top of the syringe barrel.No other defects or imperfections were observed.A device history record review was completed for provided material number 306595, lot 2101467.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

On (b)(6) 2023, when the patient finished the fluid infusion and the nurse closed the indwelling needle for the patient, it was found that the pre-it was reported that the bd posiflush¿ normal saline syringe was damaged, cracked.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, when the patient finished the fluid infusion and the nurse closed the indwelling needle for the patient, it was found that the pre-filled catheter irrigator had a crack in the wall of the syringe and leakage, and the pre-filled catheter irrigator was replaced in time without causing harm.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17909697
• MDR Text Key: 325362549
• Report Number: 1911916-2023-00758
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065951
• UDI-Public: (01)30382903065951
• 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,Followup
• Report Date: 10/12/2023

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 Catalogue Number: 306595
• Device Lot Number: 2101467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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