MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; INSULIN SYRINGE WITH NEEDLE

Catalog Number 928857

Device Problems Device Markings/Labelling Problem (2911); Material Twisted/Bent (2981)

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

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insulin syringe with bd ultra-fine¿ needle was missing the printed scale markings and had a bent barrel.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: customer returned (17) loose 1/2cc, 8mm syringes.Customer states that lines and numbers are missing from the syringe and the barrel is bent.All returned syringes were examined and all exhibited varying degrees of the scale to be missing.Also, one sample exhibited a bent barrel.Samples will be forwarded to manufacturing (holdrege) on 09nov2018 for further review.On 12nov2018, holdrege received seventeen (17) loose 0.5ml, 8mm syringes from reported batch# 8022776.All samples were decontaminated per hstr-17 and hqa-68 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.All of the returned samples were noted to have varying degrees of missing or scratched scale print markings along the full length of the print region on the syringe barrel surface.Additionally, one (1) returned sample was noted to have been severely damaged, specifically between the 19u-25u (19-25 units) and the 40u to >50u (40-50+ units) scale markings.The damage appears to have been a combination of a crushing and heating force, as the material is noted to have been compressed and apparently affected with a high degree of heat.It should also be noted that the damage extends through the width of the syringe barrel, including the plunger rod.For the missing/scratched print, the most likely root cause is either a damaged print pad or a dirty dr blade on the printer operation.In either case, the defect would be considered to be transient, as the pads and dr blades are changed/cleaned at regular intervals throughout the day.For the damage to the syringe barrel noted within the one (1) sample, this type of defect is most usually caused by a jaw jam on the ffs (form fill & seal) equipment.When this type of event occurs, any portion of the syringe and/or component may be involved in the jam and can exhibit varying degrees of damage.In most cases, the result is an inoperable device to the end user.Capa 162566 was initiated by the holdrege plant to address scratched/missing print and the associated root cause(s).A review of the device history record was completed for batch# 8022776.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200737445] noted that did not pertain to the complaint.There was one (1) notification [200737733] noted for ink rings.There was one (1) notification [200737777] noted for missing zero line.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for scale marking missing and barrel bent on lot # 8022776.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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 bd insulin syringe with bd ultra-fine¿ needle was missing the printed scale markings and had a bent barrel.No serious injury or medical intervention was reported.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8052181
• MDR Text Key: 126651146
• Report Number: 1920898-2018-00847
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 928857
• Device Lot Number: 8022776
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other