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

Catalog Number 306546

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: this is the first complaint for lot# 7244533 for the same defect or symptom.There was no documentation of issues for the complaint of batch 7244533 during this production run.Investigation comments: all our inspections and testing performed while manufacturing this batch were accepted.No rejections were documented.Update jan 12, 2017.We received the sample.It came in a plastic ziploc bag.The barrel label confirms the lot#7244533, it has the plunger rod- stopper and it is empty (no saline solution).It has attached to the luer tip a blue hub.A visual inspection was performed using a 10x magnifier lens, the barrel has no damages or cracks.The hub attached to the syringe has a hole about 1/16¿ long.This hub is not part of our syringe, it was attached by our customer.Product within specification? yes/no.Root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.Update 1/12/2018.During the sample analysis it was confirmed a damaged hub.This hub is not part of our posiflush syringe.The hub supplier is unknown.We will keep the sample in case it is needed for any further investigation.

Event Description

It was reported the bd posiflush¿ normal saline syringe hub was cracked and leaked blood and saline fluid.Found during use.No exposure to bloodily fluid occurred.No medical intervention was noted.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH SYRINGE
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7195275
• MDR Text Key: 97916279
• Report Number: 1911916-2017-00411
• 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: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7244533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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
• Patient Outcome(s): Other