MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML 18G 1-1/2IN; PISTON SYRINGE

Catalog Number 59008588

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 1107122 our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample was provided to aid in our investigation.Our engineers were able observe foreign material located within the tubing.Compositional testing of the foreign material positively identified it as a chemical constituent of the lubricant used during manufacture.Hardened lubricant is most likely caused by the excess application of lubricant in the barrel of the device.Currently visual inspections are conducted on all fished goods prior to packaging to control this kind of non-conformance.To prevent a reoccurrence of this issue we have issued a notification of this issue to the appropriate associates.The latex is most likely originating from the vial rubber, which was damaged during puncture of the iv spike.

Event Description

It was reported that syringe 50ml 18g 1-1/2in contained foreign matter.The following information was provided by the initial reporter: "foreign substances in syringe.".

• Brand Name: SYRINGE 50ML 18G 1-1/2IN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12703038
• MDR Text Key: 278623058
• Report Number: 2243072-2021-02595
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 10/07/2021

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: 07/11/2024
• Device Catalogue Number: 59008588
• Device Lot Number: 1107122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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