MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD RELION INSULIN SYRINGE 1ML, 31G

Catalog Number 311748

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problems Pain (1994); Tissue Damage (2104); Burning Sensation (2146)

Event Date 10/03/2015

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: this device does not have an expiration date.Evaluation: it is unknown if a sample is available for evaluation.Upon completion of the investigation, a supplemental mdr will be filed.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 4349700.

Event Description

It was reported that during her insulin injection using a bd relion insulin syringe, the customer felt a burning sensation after half of the insulin had been administered.She removed the device from the site and noted the needle was not attached to the syringe.The site bubbled up and was painful.The customer went to the emergency department and had an unspecified imaging study and the needle was removed surgically.The stitches were removed on (b)(6) 2015.The customer states that the device was not reused.

Manufacturer Narrative

Evaluation: the customer returned one used device in an open poly bag with the shelf carton from lot # 4349700.The returned syringe was examined and exhibited a broken cannula.A microscopic examination of the returned sample revealed characteristics such as residual bends on the broken hub 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.Conclusion: the reported issue cannot be confirmed based on the results achieved from the returned samples.An absolute root cause for this incident cannot be determined.

• Brand Name: BD RELION INSULIN SYRINGE 1ML, 31G
• 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: 5178664
• MDR Text Key: 29291608
• Report Number: 1920898-2015-00004
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 311748
• Device Lot Number: 4349700
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention