MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE

Catalog Number 324916

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Disability (2371); Device Embedded In Tissue or Plaque (3165)

Event Date 07/12/2015

Event Type  Injury  

Manufacturer Narrative

A sample is not available for evaluation.However, a no sample investigation will be conducted and upon completion of the investigation, a supplemental report will be submitted.

Event Description

It was reported that at approximately 7:00 am on (b)(6) 2015, as a consumer used a bd ultra-fine insulin syringe to inject niato medication into his penis prior to sexual intercourse, the needle broke off and remained in the corpus cavernosum of his penis.The patient went to a hospital and was hospitalized for two days.While in the hospital he received two ultrasounds to locate the broken needle and had surgery in an attempt to remove it.The surgery was unsuccessful as the needle was too deep within the consumer's penis and the doctor felt it was too risky to continue.On (b)(6) 2015 the patient had a follow up appointment with a urologist.As of the date of this report the needle remains inside the consumer's penis.The consumer also reported that he is currently unable to have sexual intercourse and that he has been treated with antibiotics (cephalexin and neomycin sulfate bacitracin) and pain medications (nimesulina and dipirone).At present, the consumer states that he is not in pain but that the incident has caused a "great nuisance.".

Manufacturer Narrative

Results: a sample is not available for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot number 5082818.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.A sample is not available for evaluation.

Manufacturer Narrative

Correction: the date of event reported on the initial mdr was entered as (b)(6) 2015.The date of event should have been entered as (b)(6) 2015.

• Brand Name: BD ULTRA-FINE¿ INSULIN 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: 5329951
• MDR Text Key: 34483890
• Report Number: 1920898-2015-00010
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 324916
• Device Lot Number: 5082818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• 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): Hospitalization; Required Intervention