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

Catalog Number 309628

Device Problem Off-Label Use (1494)

Patient Problem Reaction (2414)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: three sealed packaged 1ml ll syringes were received, confirmed to be from batch #7271990 (p/n (b)(4)).The samples were visually evaluated.A small amount of silicone residue was observed on the edge of the stopper surface after breakout.The amount of silicone observed was normal and expected amount for this product per product specification.No visual defects were observed in the returned product samples.Bd has received reports of certain adverse events involving bd¿s 1ml hypodermic syringes, 30g hypodermic needles and 19g filter needles syringes when used for intraocular injections.The intraocular use of these products has been associated with events such as ¿floaters¿ and endophthalmitis (inflammation of the interior of the eye).Bd has not specifically developed or validated these products for use in ophthalmic applications, therefore use of these bd products for intraocular injections would require the drug product manufacturer to conduct validation and stability testing to confirm that the syringe and needle products are appropriate for intraocular injection of the drug product.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.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.

Event Description

It was reported that the bd syringe luer-lok¿ tip was used to inject "apl-2 investigational medication" in the eye, and the patient had an adverse reaction from the silicone in the syringe.This syringe is not intended for eye injections.The following information was provided by the initial reporter: "an adverse reaction due to silicone in the syringes" incident date (what date did patient have the reaction)? (b)(6) 2020.Batch/lot #: 7271990.What kind of "adverse" reaction did patient have? describe.The patient reported seeing spots/floating dots throughout his vision starting immediately after the injections and they are still present currently.Is this the first time patient had used this (type/brand) syringe before? no, this same syringe and lot were previously used at first visit on (b)(6) 2020.What medication was being used in the syringe? apl-2 investigational medication was it a new medication? to the patient, no it was not.They have received one previous injection with this same medication.If patient used the medication before, was med from a new pharmaceutical manufacturer? no, not that we at the site are aware of.Did patient require medical attention/take anything to alleviate/relieve reaction? at this time they have opted to observe and see if the silicone oil will break into smaller and less noticeable particles.The only option to rid the patient of the silicone is a vitrectomy and thus far the patient has not wanted to take that step.

• Brand Name: BD SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11321991
• MDR Text Key: 268055772
• Report Number: 1213809-2021-00080
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: 00382903096282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 309628
• Device Lot Number: 7271990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• 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