MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO¿FINE+ INSULIN SYRINGE

Catalog Number 324876

Device Problem Difficult to Remove (1528)

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

Event Date 06/02/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(6).

Event Description

It was reported with the use of the bd micro¿fine+ insulin syringe there was an issue with difficult plunger movement.It was stated ¿the customer had a syringe that is crooked and unusable because the plunger did not move properly.Consumer thought that it was a single incident but yesterday he found another bent syringe (from another bag).¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.

Event Description

It was reported with the use of the bd micro¿fine+ insulin syringe there was an issue with difficult plunger movement.It was stated ¿the customer had a syringe that is crooked and unusable because the plunger did not move properly.Consumer thought that it was a single incident but yesterday he found another bent syringe (from another bag).¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: two investigations were carried out.Franklin lakes investigation summary: customer returned (2) loose 1/2cc, 8mm u40 insulin syringes with a photo of the shelf carton from lot # 7142850.Customer states that the syringe is pretty crooked and unusable because the plunger did not move properly.Both returned syringes were examined and both exhibited a bowed barrel.Both samples were also tested and both plunger rods were able to move in the barrel without any observed defects.Samples were forwarded to manufacturing (holdrege) on 13jul2018 for further review.Holdrege investigation summary: on 18jul2018, holdrege received two (2) loose 0.5ml, 8mm u-40 syringes from reported batch# 7142850.A photo of the shelf carton associated with these complaint samples was received by franklin lakes and attached to the parent record (pr432877).All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed by bd franklin lakes were noted.Probable root cause(s) include, but are not limited to: a defect causing bowed barrels during molding of the component; components stored in totes for an extended period of time which can cause some minor bowing (as noted within the returned samples) and/or a excess force applied to the component [barrel] during any portion of the assembly process.At this time, it is unable to be determined which of these may be correct.In any case, the device was noted to perform as expected, thus, the observations reported by the complainant are of a cosmetic nature only.A review of the device history record was completed for batch# 7142850.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications (b)(4) noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for damaged syringe and the 1st related complaint for plunger difficult to move on lot # 7142850.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bowed barrel).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (plunger difficult to move).Based on the above, no capa is required at this time.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 with the use of the bd micro¿fine+ insulin syringe there was an issue with difficult plunger movement.It was stated ¿the customer had a syringe that is crooked and unusable because the plunger did not move properly.Consumer thought that it was a single incident but yesterday he found another bent syringe (from another bag).¿ there was no report of injury or further medical intervention.

• Brand Name: BD MICRO¿FINE+ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7642717
• MDR Text Key: 112561375
• Report Number: 1920898-2018-00471
• Device Sequence Number: 1
• Product Code: FMF
• 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,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 324876
• Device Lot Number: 7142850
• Date Manufacturer Received: 06/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other