MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML POSIFLUSH LA; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306565

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

Patient Problem Inflammation (1932)

Event Date 08/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: a device history review was completed regarding material number 306565 and lot number 0014635.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation of this complaint, three picture samples were received for evaluation by our quality team and they all showed a syringe in its sealed packaging flow wrap.As a physical sample was unavailable for return, a thorough sample investigation could not be completed.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Investigation conclusion: 3 photos were provided.They all show a syringe in its sealed packaging flow wrap.Root cause description: since no sample was received the sample analysis could not be performed and no probable root cause can be offered.Rationale: based on the investigation carried out and with no sample for analysis the symptom reported by the customer can¿t be confirmed.No additional actions will be taken other than monitoring the complaint trend for this lot.The lot was produced for 0.967mm units; therefore, the cpm is 1.0.

Event Description

It was reported that the syringe 10ml posiflush la was involved with a patient experiencing a systemic allergic reaction during use of the device.No information has been provided detailing whether medical intervention was administered as a result.The following information was provided by the initial reporter: suspected adverse reaction to medicine: sickness and vomiting.Concomitant disease: cancer.The patient has no allergies nor other previous reactions to the medication.The reaction disappeared / got better with the interruption of the medication.Other patient information are stated within patient information tab.

• Brand Name: SYRINGE 10ML POSIFLUSH LA
• Type of Device: SALINE, VASCULAR ACCESS 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 ; 8015652341
• MDR Report Key: 10429487
• MDR Text Key: 203653905
• Report Number: 1911916-2020-00784
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/19/2020

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: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 306565
• Device Lot Number: 0014635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• 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): Other
• Patient Age: 42 YR
• Patient Weight: 62