MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGES; HEPARIN FLUSH

Catalog Number	306424
Health Effect - Clinical Codes	Respiratory Distress (2045); Reaction (2414); Sweating (2444)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is intended to report 1 of the 2 events described in the event.Another mdr will be filed for the 2nd incident.(1st event submitted with mdr report# 1911916-2018-00229) the customer's address is unknown.Unknown, washington (wa) , 0000 usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
¿it was reported that on two occasions ((b)(6)), after 30 minutes of pushing iv saline, patient experienced a severe reaction (coughing, couldn't breathe, cold sweats).Patient also used heparin flush but thinks the issue was from the saline more so than the heparin.Patient went to the er on both occasions and was told that nothing was able to be determined.Er checked the patient's lungs, checked for embolism, etc.¿ there was no additional specific information on the medical interventions received.
Additional Manufacturer Narrative
Five 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.There was no documentation of issues for the complaint of batch 716087n during this production run.There was no documentation of issues for the complaint of batch 723060n 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¿ HEPARIN LOCK FLUSH SYRINGES
• Common Device Name: HEPARIN FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7519640
• Report Number: 1911916-2018-00230
• Device Sequence Number: 1862657
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 306424
• Device Lot Number: 716087N
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018; 05/01/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 05/31/2018; 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention