MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SYRINGE

Catalog Number 306594

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 08/10/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd posiflush¿ syringe was used and the patient had an allergic reaction.This was discovered after use.The following information was provided by the initial reporter: patient, female, was admitted to hospital on (b)(6) 2019 for "chronic superficial dermatitis".After infusion at 17:01 on (b)(6), she was flushed with a flush.After half an hour, the patient developed an allergic reaction.On the chest and back of both upper and lower limbs, there were rashes of different sizes , accompanied by obvious itching.Immediately, 10 mg of chlorpheniramine maleate injection and 5 mg of dexamethasone sodium phosphate injection was injected intramuscularly.After half an hour, the rash subsided.Recurrence, no flusher after use.

Event Description

It was reported that bd posiflush¿ syringe was used and the patient had an allergic reaction.This was discovered after use.The following information was provided by the initial reporter: patient, female, was admitted to hospital on (b)(6) 2019 for "chronic superficial dermatitis".After infusion at 17:01 on (b)(6) 2019 , she was flushed with a flush.After half an hour, the patient developed an allergic reaction.On the chest and back of both upper and lower limbs, there were rashes of different sizes , accompanied by obvious itching.Immediately, 10 mg of chlorpheniramine maleate injection and 5 mg of dexamethasone sodium phosphate injection was injected intramuscularly.After half an hour, the rash subsided.Recurrence, no flusher after use.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD POSIFLUSH SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8967368
• MDR Text Key: 156713621
• Report Number: 1911916-2019-00919
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

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: 10/31/2021
• Device Catalogue Number: 306594
• Device Lot Number: 8298503
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention