MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ SP SYRINGE

Catalog Number 306575

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

Patient Problem Anaphylactoid (2218)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that after using a 10 ml bd posiflush¿ sp syringe, the patient experienced anaphylaxis and was admitted to the icu for treatment.

Manufacturer Narrative

Investigation: we have been provided with an opened shelf carton, with 32 units of posiflush¿ sp unopened.Since the described circumstances have been observed during use, this can not be replicated with sample evaluation.Complaint trending review of this lot and product family for this issue reveals no other complaints.A bhr for the reported batch was conducted confirming this was released according to defined specifications and requirements including sterilization and final lab testing: there were no qn's or issues associated with batch # 7081385.There is no documentation for any issue affecting the saline solution.All inspections performed from filling to case pack were acceptable.Controls in place at manufacturing side have been reviewed and found acceptable including: - bioburden tested during week days (monday to friday).- overkill sterilization process's.The sterilization process is challenged and re-qualified annually.- environmental testing within the filling area on a weekly basis.- the solution is filtered twice before it is filled in syringes (note: once when transferring to the hold tank and again at the fill machine).- endotoxin testing is performed per cycle.- bioburden testing on the components used to assemble the syringes, performed during week days (monday to friday).- continous online monitoring of the wfi water quality (note: this is for toc and conductivity, not microbial requirements).- bioburden and endotoxin testing of the usp purified water and wfi systems, performed during week days.- weekly endotoxin testing of the pure steam system.Part lots have also been reviewed: - barrel # 7075419; plunger rod #7075422, #7013231 and #6356213; tip cap # 7075397, #7069265 and #7061097: no problems, defects or qn related to the reported issue were found.- stopper # 7075403: no problems, defects or qn related to the reported issue were found.- saline solution # 7075424 and 7075423: no problems, defects or qn related to the reported issue were found.The returned samples do not present any special characteristic that could cause allergic reaction.We cannot confirm the reported issue.After bhr and manufacturing records review, there were no issues documented related to the reported complaint.There were no qns issued during the production of batch 7081385 and all inspections were performed with correct results.Therefore, it has not been found any specific circumstances, from manufacturing process, that could explain the described complaint.

• Brand Name: 10 ML BD POSIFLUSH¿ SP SYRINGE
• Type of Device: 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: 7004286
• MDR Text Key: 91130966
• Report Number: 1911916-2017-00288
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K003553
• 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,Followup
• Report Date: 12/11/2017

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?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 306575
• Device Lot Number: 7081385
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 10/12/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• 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