MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 5 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; INTRAVASCULAR CATHETER

Model Number	306545
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using 5 ml bd posiflush¿ normal saline syringe, in 10 ml syringe foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: customer has a contaminated flush syringe with some type of foreign substance in the solution.
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: it was reported the flush syringe had foreign substance in the solution.To aid in the investigation, one sample with no packaging flow wrap and one photo was provided for evaluation by our quality team.A visual inspection was performed and there is a white foreign matter in the syringe.No other defects or imperfections were observed.The sample was sent to a laboratory for analysis.The analysis confirmed the foreign matter was a matched closest to plastic.This defect could occur if the syringe barrel was not ejected during the first attempt from the molding process, but after the second or additional attempts which would induce the plastic particles from the top part of the syringe barrel.A device history record review was completed for provided material number 306545, lot number 2033765.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.The sample will be shown associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.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.Probable root cause.The sample has been sent to a laboratory for analysis of the foreign matter.This investigation summary will be updated when the laboratory analysis has been received.The laboratory report has confirmed the foreign matter as polypropylene with 75.25% matching.It could be possible that the syringe barrel was not ejected the first time from the molding press.It could have happened after the second or more attempts, inducing the plastic particles from the top part of the syringe barrel.The sample is to be shown to the associates for awareness.

• Brand Name: 5 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• 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: 14121619
• Report Number: 1911916-2022-00194
• Device Sequence Number: 14536769
• Product Code: FOZ
• UDI-Device Identifier: 30382903065456
• UDI-Public: 30382903065456
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K003553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2025
• Device Model Number: 306545
• Device Catalogue Number: 306545
• Device Lot Number: 2033765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown