MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL; PISTON SYRINGE

Model Number 309628

Device Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)

Patient Problems Endophthalmitis (1835); Loss of Vision (2139)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 1ml ll was damaged and had scale marking issues.The following information was provided by the initial reporter: material no.: 309628 batch no.: 9112923.It was reported that patient developed acute endophthalmitis of the right eye and a vision loss after eylea injection.Provider states that there was a syringe malfunction due to crooked syringe markings and warped handle, but provider was able to administer medication appropriately.Patient returned to clinic with intraocular inflammation in the injected eye.Complaint description: on (b)(6) 2020, ophthalmologist did an eylea injection on (b)(6) 2020.Patient now has acute endophthalmitis of the right eye and a vision loss.When the injection was preformed it was noted that the eylea syringe markings were skewed.Provider states that there was a syringe malfunction due to crooked syringe and warped handle but provider was able to administer medication appropriately.Patient returned to clinic with intraocular inflammation in the injected eye." additional questions with complainant responses: when was the damage noted? during withdrawal from the vial.Was the kit tamper sealed prior to use? yes.How were the components handled upon receipt at the office? the eylea is received in a cold packed box inside a cooling container.Upon arriving at the clinic it is immediately placed in temp tracked refrigerator and not removed until time of injection.

Event Description

It was reported that syringe 1ml ll was damaged and had scale marking issues.The following information was provided by the initial reporter: material no.: 309628 batch, no.: 9112923.It was reported that patient developed acute endophthlmitis of the right eye and a vision loss after eylea injection.Provider states that there was a syringe malfunction due to crooked syringe markings and warped handle, but provider was able to administer medication appropriately.Patient returned to clinic with intraocular inflammation in the injected eye.Complaint description: on (b)(6) 2020, ophthalmologist did an eylea injection on (b)(6) 2020.Patient now has acute endophthalmitis of the right eye and a vision loss.When the injection was preformed it was noted that the eylea syringe markings were skewed.Provider states that there was a syringe malfunction due to crooked syringe and warped handle but provider was able to administer medication appropriately.Patient returned to clinic with intraocular inflammation in the injected eye.".Additional questions with complainant responses: when was the damage noted? during withdrawal from the vial.Was the kit tamper sealed prior to use? yes.How were the components handled upon receipt at the office? the eylea is received in a cold packed box inside a cooling container.Upon arriving at the clinic it is immediately placed in temp tracked refrigerator and not removed until time of injection.

Manufacturer Narrative

H.6.Investigation: three photos and one loose 1ml syringe with clear fluid droplets inside were received and evaluated.It was observed in each of the photos and the physical sample, each side of the flange was bent with one side bent downwards at an 80-degree angle one side was bent upwards at approximately a 30-degree angle.The printed scale was also skewed and shifted upwards away from the tip and affected volumetric accuracy of the device.The volumetric accuracy and damage defects were rejectable per product specification.Potential root cause for the bent flange and scale marking defects are associated with the marking process.The bent flange was likely due to a jam and/or mistiming which led to the barrel being misoriented and incorrectly printed.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 eye).Bd has not specifically developed or validated these claims products for use in ophthalmic applications, therefor 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.

• Brand Name: SYRINGE 1ML LL
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11283842
• MDR Text Key: 230454816
• Report Number: 1213809-2021-00061
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2024
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 9112923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other