MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 309628

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter e-mail: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the packaging of the bd¿ tuberculin syringe with bd precisionglide¿ detachable needle is damaged.Reports stated there are black marks on the outside and was incorrectly sealed.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: two packages were received and confirmed to be from batch #7200757 (p/n 309628).2 packaged sealed 1ml ll syringes were received and confirmed to be from batch #7200757.1 package was from cavity 01 and had what appeared to be a piece of top web and bottom web trim sealed with it.The seal did not appear to be broken.1 package was from cavity 02 and had sticky clear tape on 3 sides attached over the edges.The package appears to have been opened on the peel tab side and taped shut after that.There is evidence of full seal grid marks present on the bottom web where the seal was broken, indicating it was fully sealed at one point.Furthermore, a device history record review showed no rejected inspections during the production of the provided lot number that could have contributed to the reported defect.A potential root cause for trim in the package is during seal station repair, the web is trimmed to gain access for repair.It is possible the trim was not properly cleared once the repair was complete and became inadvertently sealed in the product that followed.Next, for taped package personnel are not following procedure.Moreover, for trim the impact is considered limited to a few pieces, therefore no corrective actions are recommended at this time based on defective rate identified.However, management was notified to address personnel not following procedure for taped package.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7422166
• MDR Text Key: 105345552
• Report Number: 1213809-2018-00221
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: 00382903096282
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 309628
• Device Lot Number: 7200757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other