MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SP; SALINE FLUSH

Catalog Number 306574

Device Problem Fungus in Device Environment (2316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary a photo was received in the columbus plant for evaluation.The picture shows a 5ml syringe, the 306574 catalog number is shown on the barrel label.The plunger rod- stopper are assembled.The tip cap threads portion is assembled to the tip of the syringe, the rest of the tip cap is missing.The picture shows an irregular area where the tip cap got broken off.This is the first time ever this type of damage has been reported/ seen.Failure mode is confirmed.Root cause could not be determined.During the production of batch 7139805 there is no documentation of any issues or rejections for tip caps broken off or other kind of tip cap damage.All our inspections performed while manufacturing this batch were accepted; no rejections were documented.There were no qns issued during the production of this batch listed in the complaint.Investigation conclusion this is the first complaint to the batch 7139805 for the same defect or symptom.During the production of batch 7139805 there is no documentation of any issues or rejections for tip caps broken off or other kind of tip cap damage.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.On (b)(6) 2017 a picture was received: the picture shows a 5ml syringe, the 306574 catalog number is shown on the barrel label.The plunger rod- stopper are assembled.The tip cap threads portion is assembled to the tip of the syringe, the rest of the tip cap is missing.The picture shows an irregular area where the tip cap got broken off.First time ever this type of damage is reported/ seen.Product within specification? ¿ yes ¿ no root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There were no issues documented about any type of tip cap damages.It is recommended to perform an analysis on the actual sample, when available.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.On (b)(6) 2017 a picture was received: the picture shows a 5ml syringe, the 306574 catalog number is shown on the barrel label.The plunger rod- stopper are assembled.The tip cap threads portion is assembled to the tip of the syringe, the rest of the tip cap is missing.The picture shows an irregular area where the tip cap got broken off.First time ever this type of damage is reported/ seen.Product within specification? ¿ yes ¿ no root cause description root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There were no issues documented about any type of tip cap damages.It is recommended to perform an analysis on the actual sample, when available.Dhr/bhr -there were no issues documented during the production of this batch for discoloration/variation in color/cloudy.

Event Description

It was reported that before use, a bd posiflush¿ sp was found with a molding defect.¿the white cover would break at the connecting point of screw¿.There was no report of injury or medical intervention needed.

• Brand Name: BD POSIFLUSH¿ SP
• Type of Device: SALINE 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: 7097569
• MDR Text Key: 94933708
• Report Number: 1911916-2017-00338
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 306574
• Device Lot Number: 7139805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• 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): Other