MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381433

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); No Code Available (3191)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a patient fell and the 20 g x 1.00 in.Bd insyte¿ autoguard¿ shielded iv catheter in his forearm was caught between his bed and bedside table.The catheter broke of in the patient's arm and he had surgery to remove it.The initial reporter also states that the patient is currently "fine".

Manufacturer Narrative

Investigation summary: lot analysis device/batch history record review: yes.Reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable (mdr).Findings: as this complaint was a mdr; -dhr review was performed on the following lot number: 7101570 ¿ the lot number was built on (b)(4).Per review of the dhr it was concluded that all required challenges samples and testing was performed per specifications (b)(4), in accordance with the in-process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Qn / sap database review: no.Reason: a review of the qn/sap database is not required for a s1 - o1 level a investigation per (b)(4).The peura (end user risk analysis): yes.Reason: the peura is required for all mdr reportable investigations.Findings: rm5835 rev 11 version i was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations: although observations and testing could not be performed because a sample was not received for investigation, there was a photos supplied by the customer that was reviewed.Photo one ¿ displayed a retracted needle and a 20ga catheter/adapter in the needle cover photos two ¿ displayed a retracted needle in a plastic bag with the (b)(4).Investigation samples(s) meet manufacturing specifications: unknown; the unit described with this incident report was not provided for evaluation.Conclusions: the defect of catheter broke/separated after placement, as stated in the subject of the product incident report (pir), could not be confirmed based on the review of the photos submitted by the customer.Did the evaluation confirm the customer¿s experience with the bd product? no; the customer experience was not confirmed; based on the review of the photos submitted by the customer.Were we able to reproduce the customer's experience with the bd product? no; the customer experience was not reproduced.Was the device used for treatment or diagnosis? treatment.Root cause: relationship of device to the reported incident: indeterminate ¿ the photos provided for this incident did not reveal the reported incident.Comment: without a sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.

• Brand Name: 20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6717202
• MDR Text Key: 80158147
• Report Number: 1710034-2017-00117
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 381433
• Device Lot Number: 7101570
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2017
• 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