MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. NEEDLELESS DISPENSING PINS; NEEDLELESS DISPENSING PIN WITH ULTRASITE VALVE

Model Number US10

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A total of four (4) unused, unopened samples, in packaging indicating the reported lot number 0061335671, were received for evaluation.Upon visual inspection, all four samples exhibited tears / rips in the paper backing of the blister packages.The tears were all near the center of the package, measuring between approximately 0.25 inches to 0.375 inches.As an immediate action, (b)(4) contained and restricted all remaining inventory of the reported catalog number 412027 in order to perform visual inspection for any damages to the blister package or lid stock.In addition, (b)(4) has initiated a corrective action and preventive action (capa) to further investigate root cause, identify corrective actions, and to remediate, as necessary.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the distributor: reports a field complaint was received because the packaging of the dispensing pin had a tear in it.The reporting company quarantined their current inventory and performed a 100% inspection.Out of (b)(4) units inspected, (b)(4) units were found with punctures / tears.A total of (b)(4) units were quarantined from the field and replaced with inspected units.As of the date of this report, there has only been one complaint of this nature received from the field.

• Brand Name: NEEDLELESS DISPENSING PINS
• Type of Device: NEEDLELESS DISPENSING PIN WITH ULTRASITE VALVE
• 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: 5579529
• MDR Text Key: 43300944
• Report Number: 2523676-2016-00204
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: US10
• Device Catalogue Number: 412027
• Device Lot Number: 0061335671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2523676-41416-001-R
• Patient Sequence Number: 1