MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH SYRINGE

Catalog Number UNKNOWN

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

Patient Problem Anaphylactic Shock (1703)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).Medical device expiration date: unknown.The customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the patient experience allergic reactions after using unspecified bd¿ posiflush syringe.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that the patient experienced allergic reactions when using posiflush syringes.Event description per email states: pt asking for the moc for our ns and heparin posiflush syringes.She states that she was using our ns posiflush syringes 2 years ago and was experiencing anaphylactic reactions.She now to needs to have a cvad placed and will need to use the ns and heparin posiflush again and needs to know what they are made of that could be causing this reaction.She also states she is allergic to gadolinium and has a metallic taste and smell when she used the ns flushes.

Event Description

It was reported that the patient experience allergic reactions after using unspecified bd¿ posiflush syringe.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that the patient experienced allergic reactions when using posiflush syringes.Event description per email states: pt asking for the moc for our ns and heparin posiflush syringes.She states that she was using our ns posiflush syringes 2 years ago and was experiencing anaphylactic reactions.She now to needs to have a cvad placed and will need to use the ns and heparin posiflush again and needs to know what they are made of that could be causing this reaction.She also states she is allergic to gadolinium and has a metallic taste and smell when she used the ns flushes.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

• Brand Name: UNSPECIFIED BD POSIFLUSH SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10475402
• MDR Text Key: 205101484
• Report Number: 2243072-2020-01333
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other