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

Catalog Number 306546

Device Problem Microbial Contamination of Device (2303)

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

Event Date 09/07/2022

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 while using bd posiflush¿ normal saline syringes, mold was found on the syringes.There was no report of patient impact.The following information was provided by the initial reporter: sealed flush has mold.It does seem to have penetrated inside too.The whole box has been quarantined and nothing was dispensed to any patient.

Event Description

It was reported while using bd posiflush¿ normal saline syringes, mold was found on the syringes.There was no report of patient impact.The following information was provided by the initial reporter: sealed flush has mold.It does seem to have penetrated inside too.The whole box has been quarantined and nothing was dispensed to any patient.

Manufacturer Narrative

Investigation summary: it was reported the syringe had mold and discoloration.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show two posiflush syringes in sealed packaging flow wraps.Each has a tip cap with discoloration; one is yellowish and the other one is black.No other defects or imperfections were observed.A device history record review was completed for provided material number 306546, lot number 2193626.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom of foreign matter reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be offered.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.H3 other text : see h.10.

• 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: 15497247
• MDR Text Key: 306293090
• Report Number: 1911916-2022-00530
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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 Catalogue Number: 306546
• Device Lot Number: 2193626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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