MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD LORD'S ¿ 1/2 ML 30 G × 8 MM SYRINGE; INSULIN SYRINGE

Catalog Number 326668

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.(b)(4).

Event Description

It was reported that the plunger of the bd lord's ¿ 1/2 ml 30 g × 8 mm syringe was difficult to press.There was no report of injury or medical interventions.

Manufacturer Narrative

Investigation: customer returned (1) loose 1/2cc, 8mm syringe.Customer states that the plunger was too hard to press.The returned syringe was tested and the plunger was exercised without any observed defects.The sample was also tested and was able to draw and expel properly without any observed defects.Unable to perform dhr check due to unknown lot number.Bd was not able to duplicate or confirm the customer¿s indicated failure.

• Brand Name: BD LORD'S ¿ 1/2 ML 30 G × 8 MM SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6826195
• MDR Text Key: 84001523
• Report Number: 1920898-2017-00128
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other