MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD 1ML, 30G X 8MM INSULIN SYRINGE; PISTON SYRINGE

Catalog Number	928853
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.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.Device manufacture date: unknown.
Event or Problem Description
Material no.: 928853, batch no.: unknown it was reported that during use of the bd¿ 1ml, 30g x 8mm insulin syringe the consumer had difficulty in moving the plunger during injection and when drawing insulin.The following information was provided by the initial reporter: plunger difficult to move during injection and when he's drawing insulin.He was still able to use the syringes and get his complete dosage.
Additional Manufacturer Narrative
H.6.Investigation summary: customer returned (18) loose 1cc, 8mm syringes.Customer states that the plunger was difficult to move during injection and when drawing insulin.All returned syringes were tested and all plunger rods were able to be exercised in the barrel without any observed defects.Unable to perform dhr check for plunger rod difficult to move due to unknown lot number.Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not 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.Based on the above, no additional investigation and no capa is required at this time.H3 other text : see section h.10.
Event or Problem Description
Material no.: 928853, batch no.: unknown.It was reported that during use of the bd¿ 1ml, 30g x 8mm insulin syringe the consumer had difficulty in moving the plunger during injection and when drawing insulin.The following information was provided by the initial reporter: plunger difficult to move during injection and when he's drawing insulin.He was still able to use the syringes and get his complete dosage.

• Brand Name: BD 1ML, 30G X 8MM INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9166567
• Report Number: 1920898-2019-01101
• Device Sequence Number: 14078114
• Product Code: FMF
• UDI-Device Identifier: 00311917025292
• UDI-Public: 00311917025292
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 928853
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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