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

Catalog Number 306546

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Sweating (2444)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on two separate occasions, thirty minutes after receiving a flush from a bd posiflush¿ normal saline syringe, a patient experienced ¿a severe reaction including coughing, couldn't breathe and cold sweats¿.The patient went to the emergency room on both occasions but was told that nothing could be determined.The patient has ¿requested and is waiting for approval to be tested for serratia¿.

Manufacturer Narrative

H.6.Investigation summary: four samples were received by bd for evaluation.A quality engineer was able to inspect the samples and sent them out for ftir testing.The results of the testing were all negative and the samples passed each of test.The tests performed were an endotoxin test, ph test, sterility test, and heavy metals and iron testing.All samples were found to be within specifications and there was no observed bacterial growth when plated and incubated.Bd was unable to identify a cause for the reported issue.Bd has placed controls in their manufacturing plants to prevent contamination such as weekly bioburden testing, an overkill sterilization process, biweekly environmental testing with the filling area, the solutions are filtered twice before filling, each sterilizer was thoroughly validated before use and a continuous online monitoring of the wfi water quality.A review of the device history record of batch 7348542 revealed zero defects found during this production run.Capa not required for this event.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7523663
• MDR Text Key: 108606972
• Report Number: 1911916-2018-00227
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7348542
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention