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

Catalog Number 306547

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Fever (1858); Unspecified Infection (1930); Septic Shock (2068)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use a bd posiflush¿ normal saline syringe was found associated with reoccuring infections."she stated that her daughter is having recurring infections, the flush is done at home by a registered nurse.Her daughter was infected in (b)(6) of 2017 and again in (b)(6) of 2017 with a staph infection, (b)(6) 2017, (b)(6) 2018, (e.Coli classification).In (b)(6) of 2018 she was tested negative then positive in (b)(6) 2018, went into septic shock with high fever." was found with foreign matter as ¿the doctor noticed a tiny piece of plastic on tip of needle before use on patient.¿ there was no report of exposure, injury or medical intervention needed.(b)(4).

Manufacturer Narrative

Investigation summary: no samples were provided for evaluation.A device history review was completed and there were no documented issues for the complaint of batch 8018971 during this production run.All our inspections and testing performed while manufacturing this batch were accepted.No rejections were documented.Controls in place, at the manufacturing site: bioburden tested on a weekly basis.An overkill sterilization process is used.Environmental testing within the filling area is done on a biweekly basis.The sterilization process is challenged and re-qualified annually.The solution is filtered twice before it is filled in syringes (note: once when transferring to the hold again at the fill machine).Endotoxin testing is performed on each batch.Fill room operators are trained and qualified on gowning for the fill room environment on an annual basis.Weekly bioburden testing on the components used to assemble the syringes.Continuous online monitoring of the wfi water quality (note: this is for toc and conductivity, not microbial - weekly bioburden and endotoxin testing of the usp purified water and wfi systems.Weekly endotoxin testing of the pure steam system.Each sterilizer is thoroughly validated before used for posiflush sterilization.Investigation conclusion: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE 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: 7504946
• MDR Text Key: 107959234
• Report Number: 1911916-2018-00214
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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: Nurse
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 306547
• Device Lot Number: 8018971
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 04/25/2018
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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