MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH SF SALINE SYRINGE; INTRAVASCULAR CATHETER

Model Number 306553

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0062230, medical device expiration date: 2023-02-28, device manufacture date: 2020-03-02.Medical device lot #: 0090278, medical device expiration date: 2023-03-31, device manufacture date: 2020-03-30.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 28 bd posiflush" sf saline syringe packaging units from lot 0062230, and an unspecified number of units from lot 0090278, were found with tears in them before use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "operators found the sterile saline syringes to have a tear in the pouch" "bd lot 0062230 also has been found to have pieces with tears in the tyvek side of the pouch.".

Manufacturer Narrative

H6: investigation summary a device history record review was performed for provided lot numbers 0090278 and 0062230.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, seventeen physical samples belonging to lot number 0090278 and twenty-nine physical samples belonging to lot number 0062230 were returned for evaluation by our quality engineer team.Through examination of the samples, the product packages were observed damaged.At this time, a single cause has not been assigned for this defect.This issue has been escalated and is being investigated with plant engineering leadership.A corrective and preventive action plan has been initiated to further investigate this issue and prevent it's recurrence.The investigation has a specific focus on the handling and packaging of the blister packages.This ongoing investigation will be tracked and trended and communicated accordingly.Capa 1833142 has been raised to track the corrective actions for this packaging issue.See h.10.

Event Description

It was reported that 28 bd posiflush¿ sf saline syringe packaging units from lot 0062230, and an unspecified number of units from lot 0090278, were found with tears in them before use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "operators found the sterile saline syringes to have a tear in the pouch" "bd lot 0062230 also has been found to have pieces with tears in the tyvek side of the pouch.".

• Brand Name: BD POSIFLUSH SF SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10519165
• MDR Text Key: 228350186
• Report Number: 9616657-2020-00141
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 306553
• Device Catalogue Number: 306553
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other