MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SPINOCAN® SPINAL NEEDLE; SPINOCAN SPINAL NEEDLE WITH QUINCKE BEVEL

Model Number S2235

Device Problem Device Disinfection Or Sterilization Issue (2909)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Six (6) unused samples, in packaging indicating the reported lot # 0061426486, were received for evaluation.Upon visual observation, four of the samples exhibited partial areas with no heat seal transfer along the blister package seal.Further evaluation of the unsealed areas noted an extra layer of the paper backing material.The paper backing material appeared folded over at these areas.The remaining two samples exhibited full seal transfer of the package.The house retain samples for the reported lot # 0061426486 were pulled and were visually examined.There was full seal transfer along the packages and no other damages were observed on the blister packaging.The lot batch record was also reviewed, and there were no deviations or anomalies identified that could have potentially contributed to the reported event.A potential cause identified was that the top web of the blister paper may had inadvertently shifted during production.This sudden shift then likely caused a portion of the paper to fold over before going through the sealing process, causing a section of the blister to be improperly sealed.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.This was considered to be an isolated anomaly in the product sealing process.However, (b)(4) has shared this reported event with all applicable supervisors and personnel involved with the manufacturing and inspection of this product in order to heighten awareness regarding this failure mode.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: event # 1: reports while unpacking the case, six packages were opened compromising the sterility.There were no apparent damages to the outside of the case.

• Brand Name: SPINOCAN® SPINAL NEEDLE
• Type of Device: SPINOCAN SPINAL NEEDLE WITH QUINCKE BEVEL
• 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: 5733226
• MDR Text Key: 48504539
• Report Number: 2523676-2016-00391
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820047
• 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: 07/15/2015

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: 03/31/2020
• Device Model Number: S2235
• Device Catalogue Number: 333320
• Device Lot Number: 0061426486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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