MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PREFILLED SALINE SYRINGE

Catalog Number 306572

Device Problem Short Fill (1575)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was performed for provided lot number 9345598 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one picture sample and one physical sample were returned for evaluation by our quality engineer team.Through examination of the samples, the syringe was observed incorrectly filled.Based on the investigation results, it is believed that this incident resulted from a loose tip cap.Within the manufacturing facility, the equipment that tightens the tip cap was observed out of position.The equipment was adjusted and no further loose tip caps were found after the adjustment was made.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.Investigation conclusion: batch code: 9345598.The non-conformances were reviewed for this batch and there was no record of non-conformance associated with this batch.Conclusion(s): the returned sample and photo confirm incorrect fill in syringe.Root cause description: conclusion(s): based on the investigation, the root cause of this complaint may possibly have been a loose tip cap.A gripper device was out of position in the fill room and was adjusted.The gripper was tightened and no further loose tip caps were found after this adjustment was made.

Event Description

It was reported that an unspecified number of bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced incorrect filling, less than design specifications.Product defect was noted prior to use.The following information was provided by the initial reporter: detected problem: the pre-filled 10 ml sodium chloride syringe from has arrived pre-filled with only 3 ml and the rest of 10 ml is air, this means that it is a risk for patient safety.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10197363
• MDR Text Key: 203179427
• Report Number: 9616657-2020-00100
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9345598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2019
• 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