MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINE¿ U-40 1ML, 29G X 12.7MM INSULIN SYRINGE

Catalog Number	328504
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle of a bd micro-fine¿ u-40 1ml, 29g x 12.7mm insulin syringe was missing, and then found inside the barrel of the syringe.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: investigation summary: customer returned (1) 1cc, 12.7mm, 29g relion syringe in an open poly bag from lot # 7177610.Customer states that the needle was missing on one of the syringes and the customer noticed the needle inside the barrel of the syringe next to the rubber stopper.The returned syringe was examined and exhibited a broken cannula.The broken end of the cannula was received in the barrel of the syringe.Microscopic examination of the returned sample revealed characteristics such as residual bends on the broken hub end as well as on the free end, cracked adhesive and tubing ovality (deformation from the normally circular cross section).When viewed together, these are all indicators of bending/re-straightening mode of failure.Removal of some of the adhesive made this observation more apparent.The shield was also examined for any possible scrapes or cuts related by cannula recapping or improper shielding, however nothing was observed.A review of the device history record was completed for batch # 7177610.All inspections and challenges were performed per the applicable operations qc specifications.There were five (5) notifications [2000704730, 200704784, 200704853, 200704729, 200704852] 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 needle missing and the 1st related complaint for foreign matter (needle in barrel) on lot # 7177610.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (broken cannula and cannula in barrel) possible root causes include bending/re-straightening of the cannula by the customer and putting it in the barrel.Based on the above, no additional investigation and 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.

• Brand Name: BD MICRO-FINE¿ U-40 1ML, 29G X 12.7MM INSULIN SYRINGE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7429618
• Report Number: 1920898-2018-00243
• Device Sequence Number: 1339573
• Product Code: FMF
• UDI-Device Identifier: 00681131311625
• UDI-Public: 00681131311625
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 328504
• Device Lot Number: 7177610
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other