MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD HYPO-POSIFLUSH PREFILLED SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.

Event Description

It was reported that bd hypo-posiflush prefilled syringe sterile pouch is damaged.The following information was provided by the initial reporter: we are writing to inform you of a new complaint regarding 3 x 76210118 lot 3285240 - the blister packs were found to be torn damaging the products sterility.Please see 3 x images attached.

Manufacturer Narrative

As samples were not received for evaluation; the three (3) picture samples provided were utilized for analysis.The pictures showed damage to the blister packages.It is possible the observed damage resulted from poor perforation of the packages and/or poor separation of the blister packages.A device history record review was completed for provided material number 306572 and lot number 3285240.The review did identify two (2) non-conformances during the production process that may have contributed to this reported incident.The non-conformances were related to the perforation of the blister packages.Poor perforation was most likely caused by the cross-cut blade in the multivac machinery.This issue was resolved at the time of discovery and all affected product was scrapped.However, the issue may have been intermittently occurring prior to the point of discover; causing the involved product to be released.Regarding the separation of the blister packs, previous investigations have identified that this defect may be caused by the incorrect method of separation.It is recommended that blisters are separated on a horizontal plane.This is the first report received for this type of defect on material 306572 and lot 3285240.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD HYPO-POSIFLUSH PREFILLED SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18536513
• MDR Text Key: 333546045
• Report Number: 9616657-2024-00002
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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: Health Professional
• Device Catalogue Number: 306572
• Device Lot Number: 3285240
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1