MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; PREFILLED HEPARIN FLUSH SYRINGE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Reaction (2414); Numbness (2415)

Event Date 06/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported by a patient that she had a reaction to an unspecified bd posiflush heparin lock flush syringe.Within 15 minutes post administration, she felt numbness in her feet and hands.The patient received 30mg of prednisone for her symptoms.It was further reported by the patient's healthcare facility that the patient was seen by the facility and her own physician.There were no signs of rash or other symptoms and the patient's own physician did not send her to a hospital for treatment.

• Brand Name: UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Type of Device: PREFILLED HEPARIN FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6698759
• MDR Text Key: 79570600
• Report Number: 2243072-2017-00054
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention