MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; INTRAVASCULAR CATHETER

Catalog Number	306513
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that after using the bd posiflush¿ heparin lock flush syringe, the consumer experienced severe pain in their bowels and lower back.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
This mdr was filed in error.Symptoms of an unspecified reaction are not reportable.This may lead to customer dissatisfaction but does not constitute a reportable adverse event (not an allergic reaction or infection).
Event or Problem Description
It was reported that after using the bd posiflush heparin lock flush syringe, the consumer experienced severe pain in their bowels and lower back.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7749625
• Report Number: 2134319-2018-00105
• Device Sequence Number: 1678249
• Product Code: FOZ
• UDI-Device Identifier: 30382903065135
• UDI-Public: 30382903065135
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K011967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/29/2019
• Device Catalogue Number: 306513
• Device Lot Number: 718171N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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: Other