MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE FLUSH

Catalog Number 306595

Device Problem Insufficient Information (3190)

Patient Problem Anaphylactic Shock (1703)

Event Date 12/17/2017

Event Type  Injury  

Manufacturer Narrative

Investigation :a conclusion is not yet available as the investigation is still in progress.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that after use of a bd posiflush¿ normal saline syringe.A (b)(6) old infant who was currently hospitalized received a "clear pipe with flush at 17:00, anaphylactic shock occurred on 17:02 pm." medical intervention was required as the infant was treated by "rescue care ".¿the child was admitted into the neonatology unit due to abdominal fluid, the child has been safe after rescue care." it is also reported this batch had another two complaints of reactions in adults as they vomited after flush was given.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• 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: 7176616
• MDR Text Key: 96812109
• Report Number: 1911916-2017-00400
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2017

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: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7139550
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• 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
• Patient Age: 4 DA