MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML FILL IN 10 ML DIAMETER BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE; FLUSH SYRINGE

Catalog Number 306546

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Vomiting (2144); Complaint, Ill-Defined (2331)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

After the initial reporter, stericycle expert solutions, provided an incident report to bd, the mother of the affected patient provided bd with updated device information, catalog, and lot numbers.Two separate lot numbers were used for this incident.The information for these lot numbers is as follows: medical device lot #: 5361888, medical device expiration date: 11/30/2018, device manufacturing date: 12/27/2015.Medical device lot #: 6011624, medical device expiration date: 12/31/2018, device manufacturing date: 1/11/2016.Date of event: unknown.The date received by manufacturer has been used for this field.Results: a sample is not available for evaluation.A review of the device history records and sterilization records revealed no irregularities during the manufacture of the reported lot numbers 5361888 and 6011624.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customers indicated failure mode.(b)(4).

Event Description

It was reported that the mother of a (b)(6) patient with cerebral palsy used 10 ml fill in 10 ml diameter bd posiflush" normal saline filled syringes, purchased from east deals and treasure zone through amazon, to administer medications to her daughter.After using the syringes the patient became ill with vomiting, explosive gas, and diarrhea.The patient was seen by her physician and basic blood tests, evaluation of her seizure medication levels, and a gluten wheat test were performed.The patient was also given prilosec, which only helped for three days, and an upper endoscopy was scheduled for (b)(6) 2016.The results of these tests were not provided.

• Brand Name: 10 ML FILL IN 10 ML DIAMETER BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE
• Type of Device: FLUSH SYRINGE
• 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: 6099738
• MDR Text Key: 59777704
• Report Number: 1911916-2016-00023
• Device Sequence Number: 1
• Product Code: NGT
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: 306546
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 24 YR