MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31 G X 5/16"; INSULIN SYRINGE AND NEEDLE

Catalog Number 328418

Device Problems Break (1069); Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Swelling (2091); Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

It is unknown if a sample will be returned for evaluation.At this time, a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that as a consumer was recapping a bd insulin syringe with the bd ultra-fine needle 1ml 31 g x 5/16", the needle stuck her and broke off in a finger on her left hand.The consumer states her hand is swollen and infected, she was evaluated by both an emergency department and her primary care physician, and she has received an x-ray, pain medications, antibiotics, neosporin, and "proxy." the consumer also states that she has had 4 previous needles break off in her arm and stomach but has been able to remove three of these needles.She states that she needs to have hand surgery to remove the broken needle from her finger but cannot afford to do so because she is on disability and her insurance will not cover it.

Manufacturer Narrative

Results: (6) 1cc, 8mm, 31g syringes in an open poly bag from lot # 5348993 were returned for evaluation.All returned syringes were examined and no broken cannula was observed.Also, no needle through the shield was observed.However, 2 out of 6 samples exhibited a bent cannula.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5348993.Conclusion: an absolute root cause for this incident cannot be determined.However, our quality engineer notes that sometimes when a customer tries to remove the shield from the syringe, the needle may bend in the process.Also, a bent cannula would go through the shield as the shield was being placed on and the needle could penetrate through the shield.(b)(4) has a split image camera that checks for bent needle on every part and ejects from the process.Based on the investigation we cannot verify a manufacturing related cause of the defect.

Manufacturer Narrative

Additional information: on (b)(6) 2016, the consumer provided her discharge instructions from the emergency department where she was evaluated on (b)(6) 2016 and a dictated x-ray report.The information is as follows: age at time of event: (b)(6) years old.Describe event or problem: the x-ray report provided the following information: "findings: frontal, lateral, and oblique views of the left 4th finger.Linear metallic radiopacity measuring 6mm, possibly a needle fragment, projects in the 4th finger at the palmar aspect of the dip joint.Tip may be in the bone.No fracture seen.Impression: metallic linear foreign body consistent with needle fragment in the 4th finger at the dip joint level.Tip might be in the bone.No fracture seen.".

Event Description

The x-ray report provided the following information: "findings: frontal, lateral, and oblique views of the left 4th finger.Linear metallic radiopacity measuring 6mm, possibly a needle fragment, projects in the 4th finger at the palmar aspect of the dip joint.Tip may be in the bone.No fracture seen.Impression: metallic linear foreign body consistent with needle fragment in the 4th finger at the dip joint level.Tip might be in the bone.No fracture seen.".

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31 G X 5/16"
• Type of Device: INSULIN SYRINGE AND NEEDLE
• 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: 5792153
• MDR Text Key: 49491645
• Report Number: 1920898-2016-00019
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955235
• 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,Followup
• Report Date: 08/12/2016

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328418
• Device Lot Number: 5348993
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/03/2016; 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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): Required Intervention
• Patient Age: 61 YR