MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ SALINE POSI-FLUSH SP SYRINGE

Catalog Number UNKNOWN

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Vomiting (2144); Loss of consciousness (2418)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in the report and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that a child had a reaction after receiving a flush with the unspecified bd¿ saline posi-flush sp syringe.The symptoms reported were, ¿allergic reaction included hives in large areas, large amount of vomiting and unresponsiveness." it was reported that the child¿s course of treatment changed and required ¿cancel surgery the next day¿, as well as medical intervention of an unknown nature given ¿due to unresponsiveness¿.

Manufacturer Narrative

Sex: male.Event attributed to: required intervention.Device single use?: no.Device returned to manufacture: no.Investigation summary: as both a lot number and sample were unavailable for this incident, a full investigation consisting of a sample analysis and a device history record review could not be completed.Although a definite product code could not be confirmed, it was reported that the product in question was most likely bd posiflush¿ xs 10ml saline flush syringe (product code: 306572).In process and finished product inspections are performed on the posiflush product.During the production process, twenty units are sampled per hour for inspection of package seal and sterile barrier integrity.Eight samples each shift are then subjected to burst testing, to ensure the sterility of the sterile barrier.Prior to the fill process and during the fill process, tests are conducted for each lot, these tests include endotoxin bioburden, assay, and ph testing.Bioburden testing is again performed before the sterilization process.The fill room is subjected to environmental monitoring bi-weekly.Finished product is then sampled and thoroughly tested, these tests include a saline assay percentage, ph testing, ultraviolet testing, subvisible particulate testing, iron testing, heavy metal testing, and endotoxin testing.The above testing is in place to ensure that the product is fit for its intended use and that all standard requirements for the product are met.Based on the investigation, evidence was not found to determine that the posiflush syringe was responsible for the reported incident of reaction.A potential contributory factor may have been the other medicinal products in use or administered at the time the patient's port was flushed.Investigation conclusion: based on the investigation, evidence was not found to determine that the posiflush syringe was responsible for the reported incident of reaction.

Event Description

It was reported that a child had a reaction after receiving a flush with the unspecified bd¿ saline posi-flush sp syringe.The symptoms reported were, ¿allergic reaction included hives in large areas, large amount of vomiting and unresponsiveness." it was reported that the child¿s course of treatment changed and required ¿cancel surgery the next day¿, as well as medical intervention of an unknown nature given ¿due to unresponsiveness¿.

• Brand Name: UNSPECIFIED BD¿ SALINE POSI-FLUSH SP SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7789221
• MDR Text Key: 117304944
• Report Number: 2243072-2018-01100
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention