MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. NEEDLELESS DISPENSING PINS; MINI-SPIKE DISPENSING PIN

Model Number DP1000

Device Problems Break (1069); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.However, the house retain samples for the reported lot # 0061443308 were pulled and were visually examined.There were no holes, tears, punctures, or any other damages observed on the blister packaging.Without the actual used sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: reports poor packaging that allows for the product to easily puncture the backing, rendering the product non-sterile.This is not an uncommon occurrence and may go unforeseen.

• Brand Name: NEEDLELESS DISPENSING PINS
• Type of Device: MINI-SPIKE DISPENSING PIN
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5733255
• MDR Text Key: 48505852
• Report Number: 2523676-2016-00399
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K983794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: DP1000
• Device Catalogue Number: 412012
• Device Lot Number: 0061443308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2015
• 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