MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Catalog Number 309628

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

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 a bd 1ml syringe luer-lok¿ tip had foreign matter.The following was reported.Material no: 309628, batch no: 5049769.It was reported that a white particle was found in the syringe.Event description per customer's attached email states: "on (b)(6) 2019, the reporter contacted requesting replacement for one eylea vial.She stated that (b)(6) 2019, there was a "piece" of something that looked like a "mushroom" within the syringe.The reporter could not elaborate more as to what had occurred as she stated that it was difficult to explain.Patient received eylea dose from another vial.Complaint intake questions: could you provide a photograph that includes the lot number? yes.Note: a photograph was not received by were non-supplied components used in preparing/administering the dose? no.Was the supplied 19g filter needle used to withdraw the dose? no.Was the shipping container damaged? yes.Was the product carton damaged? no.Was the tamper evident seal present on the carton? yes.Was the tamper evident seal intact when the product carton was received? yes.Which component contains the foreign matter: syringe.Syringe location: on the inside of the syringe, in the solution.When was the foreign matter noticed: not answered.Can you describe the foreign matter in terms of shape/color/size? "white mushroom like".Does the foreign matter appear to be free-floating or fixed to the component? stuck in the hole where the needle is attached.Describe any methods used to clean the vial or components? not answered.Was the vial upright or inverted during the withdrawal? unknown.Was the dose prepared in advance? no.Additional questions: was the product stored properly prior to dose preparation? yes.Is the event a result of improper shipping? no.Is the event a result of a storage issue at the physician's office or patient home? no.Was the product prepared for administration? no.Was the product administered to the patient? no".

Manufacturer Narrative

H.6.Investigation: two photos of a loose 1ml ll syringe were received and visually evaluated.One photo displayed a close-up image of the syringe with and unknown volume of fluid and a loose white foreign matter particle in the fluid path.One photo showed a loose 1ml ll syringe with needle disassembled with the plunger rod and stopper taken apart.It appears the foreign matter is a plastic tip of a plunger rod larger than level 2 in size, which is rejectable per product specification.Potential root cause for the foreign matter defect is associated with the assembly process.Assembly records were reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Assembly defects were found during the manufacture of this batch.Adjustments were made and product was requalified per applicable aql before production resumed.Batch 5049769 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.

Event Description

It was reported that a bd 1ml syringe luer-lok¿ tip had foreign matter.The following was reported, " material no: 309628 batch no: 5049769.It was reported that a white particle was found in the syringe.Event description per customer's email states: "on 29-jan-2019, the reporter contacted requesting replacement for one eylea vial.She stated that (b)(6) 2019 there was a "piece" of something that looked like a "mushroom" within the syringe.The reporter could not elaborate more as to what had occurred as she stated that it was difficult to explain.Patient received eylea dose from another vial.Complaint intake questions: 1.Could you provide a photograph that includes the lot number? yes.Note: a photograph was not received by.2.Were non-supplied components used in preparing/administering the dose? no.3.Was the supplied 19g filter needle used to withdraw the dose? no.4.Was the shipping container damaged? yes.5.Was the product carton damaged? no.6.Was the tamper evident seal present on the carton? yes.7.Was the tamper evident seal intact when the product carton was received? yes.8.Which component contains the foreign matter: syringe.B.Syringe location: on the inside of the syringe, in the solution.9.When was the foreign matter noticed: not answered.10.Can you describe the foreign matter in terms of shape/color/size? "white mushroom like".11.Does the foreign matter appear to be free-floating or fixed to the component? stuck in the hole where the needle is attached.12.Describe any methods used to clean the vial or components? not answered.13.Was the vial upright or inverted during the withdrawal? unknown.14.Was the dose prepared in advance? no.Additional questions: 1.Was the product stored properly prior to dose preparation? yes.2.Is the event a result of improper shipping? no.3.Is the event a result of a storage issue at the physician's office or patient home? no.4.Was the product prepared for administration? no.5.Was the product administered to the patient? no".

• Brand Name: BD 1ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8471685
• MDR Text Key: 147063394
• Report Number: 1213809-2019-00402
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 309628
• Device Lot Number: 5049769
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other