MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ INSULIN SYRINGE; HYPODERMIC NEEDLE

Catalog Number	928855
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ insulin syringe had smeared scale marking on the syringe barrel.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd¿ insulin syringe had smeared scale marking on the syringe barrel.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch # 6137737 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200645778] noted for missing print.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.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: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.
Additional Manufacturer Narrative
Investigation summary: customer returned (13) 3/10cc, 8mm, 30g walgreens syringes in an open poly bag from lot # 6137737.Customer states that there are smeared markings on the syringes.All returned syringes were examined and all exhibited smeared scale markings from the 0-5 unit markings.Samples were forwarded to manufacturing (holdrege) on 09nov2018 for further review.On 12nov2018, holdrege received thirteen (13) 0.3ml, 8mm, 30g walgreens syringes in an opened polybag from batch# 6137737.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 but two (2) of the returned samples were noted to have smeared ink at or around the zero (0) line scale marking.Two (2) of the returned samples were noted to have slight smears of the scale marking, however, the result to the scale print would not have been noted to be a defect, had it been found during routine in-line inspections on the manufacturing floor.Capa 162566 was initiated by the holdrege plant to address print related quality notifications and their associated root causes.Batch# 6137737 was manufactured prior to initiation of this capa.A review of the device history record was completed for batch # 6137737 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200645778] noted for missing print.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for scale marking illegible on lot # 6137737.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 or Problem Description
It was reported that bd¿ insulin syringe had smeared scale marking on the syringe barrel.No serious injury or medical intervention was reported.

• Brand Name: BD¿ INSULIN SYRINGE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7834710
• Report Number: 1920898-2018-00672
• Device Sequence Number: 13770903
• Product Code: FMI
• UDI-Device Identifier: 00311917025278
• UDI-Public: 00311917025278
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K955235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2018

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: 928855
• Device Lot Number: 6137737
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 08/10/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 09/10/2018; 12/01/2018
• 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