MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE, 10ML FILL IN 10ML DIAMETER; FLUSH SYRINGE, SALINE

Catalog Number 306546

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Tachycardia (2095); Complaint, Ill-Defined (2331)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

The exact date of event is unknown.The customer reported the event occurred in (b)(6) 2016.Device evaluation: it is unknown if a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

The customer reports receiving home infusion of ivig.On her third round of infusion in (b)(6) 2016, when the visiting nurse flushed her iv access with the suspect device, the customer experienced an alcohol taste in her mouth and an increase in heart rate.The customer went to the doctor who prescribed 50ml benadryl iv to be administered prior to infusions and an epipen to be used as needed.The customer noted that her visiting nurse used a regular syringe instead of a bd posiflush⠁nd the consumer did not have any adverse reaction.

Manufacturer Narrative

Section h, device evaluation: result - a sample was not returned for evaluation.There were no qns or issues associated with the reported lot 6098603.There is no documentation for any bridging, or issues affecting product.All our inspections performed while manufacturing this batch were accepted; no issues or rejections were documented.Conclusion - bd was not able to duplicate or confirm the customer¿s indicated failure mode.All inspections/testing performed from molding through the case pack were acceptable with no rejections recorded.An absolute root cause for this incident could not be determined.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE, 10ML FILL IN 10ML DIAMETER
• Type of Device: FLUSH SYRINGE, SALINE
• 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: 5827041
• MDR Text Key: 50613930
• Report Number: 1911916-2016-00010
• Device Sequence Number: 1
• Product Code: FOZ
• 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: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

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?: No
• Device Operator: Nurse
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 306546
• Device Lot Number: 6098603
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention